Precision medicine strengthened its place in cancer care in the US, with over 65 agents receiving accelerated, regular, or expanded approvals in 2024. But these weren’t the only game-changing indications the regulatory agency greenlit throughout the year—label updates, biosimilar approvals, and new formulations of drugs housed under accelerated, regular, or expanded pathways also changed practice.

In addition to exciting new indications presenting crucial options for patients, several drugs missed the mark and were withdrawn from the market in 2024; these included melphalan flufenamide (Pepaxto; Melflufen), infigratinib (Truseltiq), and sacituzumab govitecan-hziy (Trodelvy) in certain populations.

“There are considerations and changes that need to occur within the different practices to accommodate [the changing field]; we want universal genetic testing provided to patients because for most tumors it’s becoming the exception of the rule to see guidelines that are not including biomarker-based approaches,” Pedro Barata, MD, said in an interview with 

Throughout the year, we covered all the critical regulatory decisions that will affect practice. Keep reading to for a list of the label updates and new formulation/biosimilar approvals as well as label updates.

Melphalan flufenamide (Pepaxto; Melflufen)

In combination with dexamethasone to treat certain patients with multiple myeloma


Previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with an 

Adult patients with locally advanced or metastatic urothelial cancer who have previously received a platinum-containing chemotherapy and PD-(L)1 inhibitor


Reduced biweekly teclistamab-cqyv (Tecvayli) dose

A reduced dose of 1.5 mg/kg every 2 weeks in patients with relapsed/refractory multiple myeloma who have achieved and maintained a complete response or greater for at least 6 months


Safety label changes for fluorouracil injection products to include additional information regarding the risk of serious adverse effects in patients with dihydropyrimidine dehydrogenase deficiency


Labeling for fludarabine phosphate (Fludarabine Phosphate Injection)

Now approved as a component of a combination regimen for the treatment of adults with B-cell CLL and for those who have not responded to or whose disease has progressed during treatment with at least 1 alkylating agent–containing regimen; additional label revisions occurred regarding dosing and removal of the boxed warning


Oral suspension formulation of ibrutinib (Imbruvica)

A label expansion for ibrutinib with an oral suspension formulation for the treatment of adult patients with CLL/SLL, Waldenström macroglobulinemia, and cGVHD after failure on at least 1 line of systemic therapy


Tepylute (formerly SH-105), a ready-to-dilute formulation of thiotepa

Nilotinib (Danziten) tablets without mealtime restrictions

Adult patients with newly diagnosed Ph-positive CML in CP and adult patients with CP and acute phase resistant or intolerant to prior therapy including imatinib (Gleevec)


Certain forms of leukemia and other cancers


Single-dose, intravenous generic formulation of paclitaxel

Paclitaxel; the biosimilar is a single-dose, generic formulation of paclitaxel comprising paclitaxel protein-bound particles (albumin-bound) for injectable suspension.


Adjuvant treatment of HER2-overexpressing breast cancer, treatment of HER2-overexpressing metastatic breast cancer, and treatment of HER2-overexpressing metastatic gastric or GEJ adenocarcinoma


Denosumab-bbdz (Wyost) and denosumab-bbdz (Jubbonti)

Denosumab (Xgeva and Prolia); both denosumab-bbdz biosimilars are the first FDA-approved denosumab biosimilars.


All indications of the reference medicines


Advancing health through innovation: New drug therapy approvals 2024. FDA. Accessed February 4, 2025. bit.ly/3WKqf0s

Articles

Precision medicine has significantly advanced in US cancer care, with over 65 agents receiving various approvals in 2024. Regulatory changes included label updates, biosimilar approvals, and new drug formulations, impacting clinical practice. Some drugs, such as melphalan flufenamide, infigratinib, and sacituzumab govitecan-hziy, were withdrawn. Universal genetic testing is increasingly essential for biomarker-based approaches. Key regulatory decisions, including reduced dosing and safety labeling changes, were made for drugs like teclistamab-cqyv and fluorouracil. New formulations and biosimilars, such as oral ibrutinib and denosumab-bbdz, were also approved.

See this full list of regulatory decisions from 2024 regarding withdrawn agents, label updates, and new drug formulations. 


Withdrawn Agents, Label Updates, and New Drug Formulations Shaped the Oncology Field in 2024

The first ever tumor-infiltrating lymphocyte (TIL) therapy to receive the go-ahead from the FDA, lifileucel (Amtagvi), gained an indication for patients with melanoma in 2024, marking an important milestone in a year with many. There were more than 65 accelerated, regular, or expanded approvals over the 365 days, and selpercatinib (Retevmo) was one of 6 agents that snagged 3 approvals. Two approvals in the brain cancer field also represented notable regulatory decisions—vorasidenib (Voranigo) was the first systemic therapy that received the greenlight from the FDA for patients with low-grade glioma in more than 20 years. 

We rounded up all the approvals from 2024 here at 

 in several articles, and in this piece, we cover a lot of ground, highlighting all agents that received the go-ahead from the FDA in the breast, gynecologic, and skin cancer fields as well as those approved for patients with solid tumors and additional cancers. Keep reading for the list with expert insights included below!

Ribociclib (Kisqali) plus an aromatase inhibitor

Adjuvant treatment of adults with hormone receptor (HR)–positive, HER2-negative stage II and III early breast cancer at high risk of recurrence. The FDA also approved the ribociclib and letrozole co-pack (Kisqali Femara Co-Pack) for the same indication.


"Although there are some new learning points that we’re going to have to discuss, this [approval] is exciting because there are now more opportunities for patients [in the curative setting] to get [therapy] from this new indication.”

The University of Texas MD Anderson Cancer Center, Houston

Inavolisib (Itovebi) plus palbociclib (Ibrance) and fulvestrant (Faslodex)

Adult patients with endocrine-resistant, 

-mutated, HR-positive, HER2-negative locally advanced or metastatic breast cancer, as detected by an FDA-approved test, following recurrence on or after completing adjuvant endocrine therapy


"Thankfully, these patients have a number of treatment options, so we need to be evaluating their survival over time. It’s exciting when you [consider] that the first data from the phase 3 INAVO120 trial [(NCT04191499), which supported the approval,] were made public in December 2023 and presented 3 days later at the San Antonio Breast Cancer Symposium—I was honored to discuss those data—and inavolisib was approved in October 2024. That’s a very great speed of getting a new approach into the clinic. It’ll take us a bit to see what happens with survival, but it’s going to offer us a lot of insights into how to treat patients in this situation.”

UCSF Helen Diller Family Comprehensive Cancer Center, California

Pembrolizumab (Keytruda) plus chemoradiotherapy

Patients with International Federation of Gynecology and Obstetrics (FIGO) 2014 stage III to IVA cervical cancer


Adult patients with FRα-positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who have previously received 1 to 3 systemic treatment regimens


"The phase 3 MIRASOL trial [NCT04209855] was aimed to develop a new treatment for [patients with] platinum-resistant recurrent ovarian cancer, which is an unmet medical need. We have very little to offer patients with platinum-resistant ovarian cancer; standard-of-care [SOC] treatments are associated with short treatment responses, low response rates, and often a lot of toxicities that make it very difficult to endure these treatments. There is a clear need for introducing new agents into this space…. All 3 end points [of MIRASOL] were met, suggesting that [mirvetuximab soravtansine] is a new SOC in platinum-resistant ovarian cancer.”

Patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy


Durvalumab and carboplatin plus paclitaxel, followed by single-agent durvalumab, for adult patients with primary advanced or recurrent endometrial cancer that is mismatch repair deficient


Pembrolizumab in combination with carboplatin and paclitaxel, followed by single-agent pembrolizumab, for the treatment of adult patients with primary advanced or recurrent endometrial carcinoma


Dostarlimab-gxly (Jemperli) plus chemotherapy

Dostarlimab in combination with carboplatin and paclitaxel, followed by single-agent dostarlimab, for the treatment of adult patients with primary advanced or recurrent endometrial cancer


"This full approval of dostarlimab [for this population] came 13 months after we received the accelerated approval in July 2023 for patients with mismatch repair–deficient disease and has been well received…. At this point, our mission was accomplished with [part 1 of the phase 3] RUBY trial [NCT03981796]. We have the full approval, the OS end point, and an all-comers indication based on strong survival data. Now we need to better understand RUBY part 2 data and the cohort of patients who will benefit from dostarlimab plus a PARP inhibitor, specifically niraparib [Zejula]. That’s the next horizon.”

University of California, Irvine School of Medicine and the Chao Family Comprehensive Cancer Center, Orange County, California

Fam-trastuzumab deruxtecan-nxki (Enhertu)

Adult patients with unresectable or metastatic HER2-positive (IHC 3+) solid tumors who have received prior systemic therapy and have no satisfactory alternative treatment options


"This is one of the most exciting tumor-agnostic approvals we’ve seen to date, and it’s going to be game-changing for many patients who maybe haven’t had such great treatment options in the past…. It’s another tumor-agnostic approval, but this time it is for a target that’s well known throughout both academia and the community alike. That’s why it’s exciting, and it joins the other tumor-agnostic approvals, which validate precision medicine. Up to this point [in April 2024], we’ve had only 6 [regimens receive] tumor-agnostic approval from the FDA.”

Baylor Scott & White Charles A. Sammons Cancer Center at Baylor University Medical Center, Dallas, Texas

Adult and pediatric patients 12 years and older with locally advanced or metastatic solid tumors harboring an 

 gene fusion or where surgical resection is likely to result in severe morbidity and who have progressed after treatment or have no satisfactory alternative therapy


Nivolumab and hyaluronidase-nvhy (Opdivo Qvantig; subcutaneous nivolumab)

For subcutaneous injection across approved adult solid tumor nivolumab indications as monotherapy, monotherapy maintenance following completion of nivolumab plus ipilimumab (Yervoy) combination therapy, or in combination with chemotherapy or cabozantinib (Cabometyx)


Adults with unresectable or metastatic melanoma previously treated with a PD-1 antibody and, if 

 V600 positive, a BRAF inhibitor with or without a MEK inhibitor


"Although it’s not going to be offered for everyone based on the safety profile, there are many young patients with melanoma or fit patients who are older who don’t have adequate standard therapies [available who can receive the agent]. Having a chance of [achieving] long-term benefit [with this therapy] is [significant].”

University of Chicago Medical Center, Illinois

For patients 6 months and older with relapsed or refractory low-grade glioma harboring a 

"[Tovorafenib] has become a very good option and one of the first standard options for this type of tumor for pediatric patients to receive oral therapy. The next question, and one of the subjects of an ongoing study that’s coming next, is whether it might become the first option that one considers. This approval is for tumors that have already grown back after standard therapy, but for some children, considering their individual features, [giving the agent in the first line may make sense].”

Fred Hutchinson Cancer Research Center, Seattle, Washington

Pediatric patients aged 2 or older who have advanced or metastatic
medullary thyroid cancer and a 

 mutation who require systemic therapy; advanced or metastatic thyroid cancer with a 

 gene fusion who require systemic therapy and who are radioactive iodine refractory, if radioactive iodine is appropriate; and locally advanced or metastatic solid tumors with a 

 gene fusion who have progressed on or after prior systemic treatment or who have no satisfactory alternative treatment options, all as detected by an FDA-approved test


Adult and pediatric patients at least 2 years of age with advanced or metastatic 

 fusion–positive thyroid cancer who require systemic therapy and who are radioactive iodine refractory, if radioactive iodine is appropriate


Experts provide insights on the 2024 FDA approvals in several different fields including solid tumors and more in this list featuring the regulatory decisions.



2024 FDA Approvals in Breast, Gynecologic, and Other Solid Tumors Represent Key Steps Forward

It was a particularly eventful year in the non–small cell lung cancer (NSCLC) field with 11 FDA approvals, but that wasn't all in the lung cancer space. The regulatory body greenlit 2 agents for patients with small cell lung cancer (SCLC) and 1 regimen for those with malignant pleural mesothelioma.

Drugs that made a notable splash throughout the year were amivantamab-vmjw (Rybrevant) which earned 3 FDA approvals in NSCLC, and durvalumab (Imfinzi) and osimertinib (Tagrisso) which snagged 2 indications each in the lung cancer field, further expanding the treatment armamentarium. 

Pembrolizumab (Keytruda) and nivolumab (Opdivo) also received 3 indications each from the FDA in 2024, with each drug receiving one of them in lung cancer. 

Keep reading to see the full list of lung cancer approvals from 2024 and insights from experts who sat down with us at 

 throughout the year to discuss their significance.

Adult patients with metastatic NSCLC harboring 

Osimertinib plus platinum-based chemotherapy

Patients with locally advanced or metastatic NSCLC harboring 

 exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test


"[There are] several different types of benefits of the combination over osimertinib alone. We’re excited to see this move forward and have the combination available to treat our patients…. [As] it’s a fairly well-tolerated medicine, it lends itself to study combinations like chemotherapy in combination with osimertinib.”

Dana-Farber Cancer Institute and Harvard Medical School, Boston, Massachusetts

Amivantamab plus carboplatin and pemetrexed

Frontline treatment of patients with locally advanced or metastatic NSCLC harboring 

 exon 20 insertion mutations, as detected by an FDA-approved test


Adjuvant treatment following tumor resection in patients with 

-positive NSCLC, as detected by an FDA-approved test


First-line treatment of locally advanced or metastatic NSCLC harboring 

 exon 19 deletions or exon 21 L858R substitution mutations, as detected by an FDA-approved test


"Amivantamab is one of the first therapeutic options I’ve seen that has shown broad activity across all 

mutations…. Now we need to work on managing and mitigating toxicities. We also need to think about the next generation of inhibitors, building upon therapies we have.”

NYU Langone Health Perlmutter Cancer Center, New York, New York

Perioperative durvalumab plus chemotherapy

Durvalumab in combination with platinum-containing chemotherapy as neoadjuvant treatment, followed by single-agent durvalumab as adjuvant treatment, for adult patients with resectable (tumors ≥ 4 cm and/or node positive) NSCLC and no known 

Adult patients with locally advanced or metastatic NSCLC harboring 

 exon 19 deletions or exon 21 L858R substitution mutations whose disease has progressed on or after treatment with an EGFR TKI


Adult patients with locally advanced, unresectable stage III NSCLC whose disease has not progressed during or following concurrent or sequential platinum-based chemoradiation therapy and whose tumors have 

exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test


Perioperative nivolumab plus chemotherapy

Nivolumab with platinum-doublet
chemotherapy as neoadjuvant treatment, followed by single-agent nivolumab as adjuvant treatment, for adults with resectable (tumors ≥ 4 cm and/or node positive) NSCLC and no known 

"We still have to define which patients need perioperative therapy vs which are sufficiently treated with a pure neoadjuvant regimen, but [this regimen] gives both patients and oncologists the option to escalate treatment if they feel the need to do so after neoadjuvant therapy and surgery.”

McGill University and Montreal General Hospital, Quebec, Canada

Adults with advanced, unresectable, or metastatic NSCLC or pancreatic adenocarcinoma harboring an 

 gene fusion with disease progression on or after prior systemic therapy


-positive locally advanced or metastatic NSCLC who did not previously receive an ALK inhibitor


Extensive-stage SCLC with disease progression on or after platinum-based chemotherapy


Pembrolizumab plus pemetrexed and platinum chemotherapy

Frontline treatment of patients with unresectable advanced or metastatic malignant pleural mesothelioma


Adults with limited-stage SCLC whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy


This full list of 2024 FDA approvals in lung cancer features insights from experts who sat down with us throughout the year to discuss their significance.

Over a Dozen FDA Approvals in 2024 Changed the Lung Cancer Field 

In a year with many firsts observed, lisocabtagene maraleucel (liso-cel, Breyanzi) became the only chimeric antigen receptor (CAR) T-cell therapy to receive a stamp of approval for adults with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). The agent also received 3 indications from the FDA in 2024, providing options for many different patient populations. Several CAR T-cell therapies also moved up in lines of therapy, providing an earlier cellular therapy for patients with select hematologic malignancies.

As the field expanded with almost 20 FDA approvals in the hematology sphere occurring in 2024, we’ve rounded up all the approvals and paired them with expert insights below!

Adult patients with newly diagnosed Philadelphia chromosome (Ph)–positive acute lymphoblastic leukemia (ALL)


"We’re very excited about the completion of the [phase 3 PhALLCON trial (NCT03589326)] and meeting the primary end points, as well as the approval of ponatinib. As the treatment of [patients with] Ph-positive ALL continues to evolve, this approval introduces more effective agents early in the treatment paradigm, potentially sparing more patients from the need of treatment at the time of relapse.”

Pediatric patients aged 1 and older with relapsed or refractory CD22-positive B-cell precursor ALL


Adult and pediatric patients 1 month or older who have CD19-positive, Ph-negative B-cell precursor ALL in the consolidation phase of multiphase chemotherapy


Expanded to include the treatment of pediatric patients with ALL and polyarticular juvenile idiopathic arthritis


Adult patients with newly diagnosed Ph-positive chronic myeloid leukemia in chronic phase (CML-CP)


Obecabtagene autoleucel (obe-cel, Aucatzyl)

Adult patients with relapsed or refractory B-cell precursor ALL


"This approval comes at a critical time, and it’s a major milestone [for] patients with ALL. Splitting the dose allows us to deliver a safe CAR T-cell therapy [with] minimal complications, and [it is] effective in the long run. [Obe-cel is also] an outpatient therapy, which will have a major impact on society and our patients’ lives. It’s a very important accomplishment that will fill a major unmet need.”

Adult and pediatric patients aged 1 and older with relapsed or refractory acute leukemia and a 

Zanubrutinib (Brukinsa) plus obinutuzumab (Gazyva)

Relapsed or refractory follicular lymphoma after 2 or more lines of systemic therapy


Adult patients with relapsed or refractory follicular lymphoma who have received 2 or more prior lines of systemic therapy


Adult patients with relapsed or refractory mantle cell lymphoma (MCL) who have received at least 2 prior lines of systemic therapy, including a Bruton tyrosine kinase (BTK) inhibitor


Adult patients with relapsed or refractory follicular lymphoma following 2 or more lines of systemic therapy


[As] we have such an active therapy in the relapsed/refractory setting, [it] will [likely] move up in the lines of [treatment] in follicular lymphoma. We have studies [examining] second-line treatment and will be [evaluating] frontline therapy with bispecific antibodies, including epcoritamab…. I believe that bispecific antibodies, including epcoritamab, will let us develop chemotherapy-free combinations resulting in excellent efficacy, minimal toxicity, and very durable responses for patients, and hopefully one day [they may] cure follicular lymphoma.”

Mayo Clinic Comprehensive Cancer Center, Rochester, Minnesota

Relapsed/refractory cutaneous T-cell lymphoma after at least 1 prior systemic therapy


Adult patients with relapsed or
refractory CLL or SLL who have received at least 2 prior lines of therapy, including a BTK inhibitor and BCL2 inhibitor


"There could be room for improvement with CAR T-cell therapy, and we’re working to figure out how to make [these agents] better in CLL. Nevertheless, having [an agent that can generate a] complete response in 1 in 5 patients who are heavily pretreated and don’t have effective options is quite significant.”

Adult patients with relapsed or refractory multiple myeloma after 2 or more prior lines of therapy, including an immunomodulatory drug (IMiD), a proteasome inhibitor (PI), and an anti-CD38 monoclonal antibody


Ciltacabtagene autoleucel (cilta-cel, Carvykti)

Adult patients with relapsed or refractory multiple myeloma who have received at least 1 prior line of therapy, including a PI and an IMiD, and whose disease is refractory to lenalidomide (Revlimid)


One thing that we have to recognize is the [limited] accessibility of CAR T-cell therapy as it stands, as well as the capacity at transplant cellular therapy centers. [We] also [should] appreciate the fact that we do have some triplet regimen options for patients in that early-relapsed setting. Having said all that, cilta-cel would be a very good option for the patients who are functionally high risk and who did not have a good first or even second progression-free survival period….The other important piece is that patients who do choose cilta-cel as an option [typically experience] a drug-free period after they’ve recovered from the CAR T-cell therapy. There are so many advantages, but we have to present those options with the caveat that logistics will be an issue.”

Memorial Sloan Kettering Cancer Center, New York, New York

Isatuximab-irfc (Sarclisa) plus bortezomib (Velcade), lenalidomide, and dexamethasone (VRd)

Adult patients with newly diagnosed multiple myeloma who are not eligible for autologous stem cell transplant (ASCT)


Adults with low- to intermediate-1–risk myelodysplastic syndromes (MDS) and transfusion-dependent anemia requiring 4 or more red blood cell units over 8 weeks who have not responded to, have lost response to, or are not eligible for erythropoiesis-stimulating agents


"Following imetelstat’s approval for patients who are transfusion dependent with lower-risk MDS, we finally have another tool in our tool set for how to treat these patients. Findings [from the phase 3 IMerge trial (NCT02598661)] will help bolster [the] approval by demonstrating that not only do patients become transfusion independent, but they also have a rise in their hemoglobin levels irrespective of whether they have other abnormalities of other blood counts.”

University of Miami Sylvester Comprehensive Cancer Center, Florida

Daratumumab and hyaluronidase-fihj (Darzalex Faspro) plus VRd

Induction and consolidation in patients with newly diagnosed multiple myeloma who are eligible for ASCT


Pediatric patients 2 months and older with steroid-refractory acute graft-vs-host disease


The movement of CAR T-cell therapy to earlier lines of therapy was among many notable advancements greenlit by the FDA in the hematologic space in 2024. 

Hematologic Oncology Field Sees Almost 20 FDA Approvals in 2024 

The gastrointestinal (GI) and genitourinary (GU) fields saw over 10 FDA approvals add to their paradigms in 2024, and throughout the year oncologists sat down with 

 to detail the significance of these regulatory decisions.

The October approval of zolbetuximab-clzb (Vyloy) for patients with HER2-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors are claudin 18.2 (CLDN18.2) positive represented the first and only approval of a CLDN18.2-targeted therapy in the US, signifying a key highlight of the year. Another notable advancement came with the expanded approval of lutetium Lu 177 dotatate (Lutathera) for those with rare pediatric somatostatin receptor–positive gastroenteropancreatic neuroendocrine tumors (NETs).

Tislelizumab-jsgr (Tevimbra) also snagged 2 indications this year, both in the GI space, and nivolumab (Opdivo) received 3 indications in 2024, including 1 approval in the GU field.

Keep reading for all of the FDA approvals from 2024 in GI/GU malignancies with expert commentary sprinkled in:

NALIRIFOX (irinotecan liposome [Onivyde] plus oxaliplatin, fluorouracil, and leucovorin)

Frontline treatment of patients with metastatic pancreatic adenocarcinoma


February
To read more, visit: bit.ly/4fluRRk

"It’s hard to show improvement in overall survival [OS] in findings from a randomized phase 3 trial in pancreatic cancer—[that] hasn’t been done since the emergence of nab-paclitaxel [Abraxane] and the FOLFIRINOX [leucovorin, fluorouracil, irinotecan, and oxaliplatin] regimen at around the same time. Since then, many studies that have been done in pancreatic cancer failed to meet their end points. The fact that [NAPOLI 3 (NCT04083235)] met its primary end point of OS [with NALIRIFOX vs gemcitabine plus nab-paclitaxel] is significant.”

Adult patients with unresectable or metastatic esophageal squamous cell carcinoma following prior systemic chemotherapy that did not include a PD-(L)1 inhibitor


March
To read more, visit: bit.ly/4ghWN9V

Pediatric patients 12 years and older
with somatostatin receptor–positive gastroenteropancreatic NETs, including foregut, midgut, and hindgut NETs


April
To read more, visit: bit.ly/3ZW6vJg

Pediatric NETs are extraordinarily rare—this is a one-in-a-million diagnosis—and the evidence base around therapies for these patients is quite thin. Fortunately, on the adult side, we’ve made a lot of progress over the past 5 or 10 years, and we frequently get questions [from] our pediatric colleagues about what the options are. Given the success of peptide receptor radionuclide therapy for adults, expanding this to children is something that we hope will be helpful.”

Winship Cancer Institute of Emory University, Atlanta, Georgia

Adagrasib (Krazati) plus cetuximab (Erbitux)

 G12C–mutant locally advanced or metastatic colorectal cancer (CRC), as determined by an FDA-approved test, who have received prior treatment with fluoropyrimidine-,
oxaliplatin-, and irinotecan-based chemotherapy


"With this approval, we have a treatment for patients who have a 

 G12C mutation within the colorectal tumor. Most directly, it means that those patients have a targeted therapy [option], but it also opens the door to targeting RAS, which is a big goal because 

 mutations are common. Approximately 45% of [patients with] CRC [have 

 mutations], and this has been a very difficult protein to target, so this is a first step. [Adagrasib] specifically targets the 

 G12C mutation, [which provides] an option for patients who have that mutation and creates a paradigm to hopefully target more 

Zolbetuximab plus fluoropyrimidine- and platinum-containing chemotherapy

First-line treatment of adult patients with locally advanced unresectable or metastatic, HER2-negative gastric or GEJ adenocarcinoma whose tumors are CLDN18.2 positive, as determined by an FDA-approved test


 October 
To read more, visit: bit.ly/4e8f47R

Previously treated unresectable or metastatic HER2-positive (immunohistochemistry [IHC] 3+) biliary tract cancer, as detected by an FDA-approved test


"This represents the first accelerated approval in biliary tract cancers for a [dual] HER2-targeted [bispecific antibody]. Zanidatamab has shown excellent antitumor activity and tolerability in patients with HER2-amplified biliary tract cancer. It’s extremely exciting and offers a new treatment option for patients with [a] very difficult[-to-treat] disease.”

Tislelizumab plus platinum- and fluoropyrimidine-

For the first-line treatment of patients with unresectable or metastatic HER2-negative gastric or GEJ adenocarcinoma whose tumors express PD-L1 (≥ 1)


Encorafenib (Braftovi) plus cetuximab and mFOLFOX6 (fluorouracil, leucovorin, and oxaliplatin)

 V600E mutation, as detected by an FDA-approved test


Adult patients with locally advanced or metastatic urothelial carcinoma harboring susceptible 

 alterations, as determined by an FDA-approved test, whose disease has progressed on or following at least 1 prior line of systemic therapy. The FDA noted that this approval amends the indication previously granted under accelerated approval for patients with metastatic urothelial carcinoma with susceptible 

alterations following prior platinum-containing chemotherapy.


Frontline treatment of adult patients with unresectable or metastatic urothelial carcinoma


Nogapendekin alfa inbakicept-pmln (Anktiva) plus BCG

Adult patients with Bacillus Calmette-Guérin–unresponsive non–muscle-invasive bladder cancer with carcinoma in situ with or without papillary tumors


Experts provide insights on the 2024 FDA approvals in the gastrointestinal and genitourinary fields in this list featuring all the regulatory decisions. 

Perspectives on FDA Oncology Approvals and Withdrawals That Shaped 2024: A Year in Review Roundup | Supplements and Featured Publications

Withdrawn Agents, Label Updates, and New Drug Formulations Shaped the Oncology Field in 2024

2024 FDA Approvals in Breast, Gynecologic, and Other Solid Tumors Represent Key Steps Forward

Over a Dozen FDA Approvals in 2024 Changed the Lung Cancer Field

Hematologic Oncology Field Sees Almost 20 FDA Approvals in 2024

Experts Comment on the GI/GU Cancer FDA Approvals From 2024