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 OncLive® 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

Approval type: Regular
Indication: 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.
Month: September
To read more, visit: bit.ly/3OYfsLQ

"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.”

Bora Lim, MD
The University of Texas MD Anderson Cancer Center, Houston

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

Approval type: Regular
Indication: Adult patients with endocrine-resistant, PIK3CA-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
Month: October
To read more, visit: bit.ly/3P2cPc6

"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.”

Hope S. Rugo, MD, FASCO
UCSF Helen Diller Family Comprehensive Cancer Center, California

Pembrolizumab (Keytruda) plus chemoradiotherapy

Approval type: Regular
Indication: Patients with International Federation of Gynecology and Obstetrics (FIGO) 2014 stage III to IVA cervical cancer
Month: January
To read more, visit: bit.ly/3BBWQyj

Mirvetuximab soravtansine-gynx (Elahere)

Approval type: Regular
Indication: 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
Month: March
To read more, visit: bit.ly/4gievu4

"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.”

Gottfried Konecny, MD
UCLA Health, Los Angeles, California

Tisotumab vedotin-tftv (Tivdak)

Approval type: Regular
Indication: Patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy
Month: April
To read more, visit: bit.ly/4gGMax5

Durvalumab (Imfinzi) plus chemotherapy

Approval type: Regular
Indication: 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
Month: June
To read more, visit: bit.ly/3ZxWgJW

Pembrolizumab plus chemotherapy

Approval type: Regular
Indication: 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
Month: June
To read more, visit: bit.ly/41CHLXO

Dostarlimab-gxly (Jemperli) plus chemotherapy

Approval type: Expanded
Indication: 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
Month: August
To read more, visit: bit.ly/3Pl1JPL

"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.”

Krishnansu S. Tewari, MD
University of California, Irvine School of Medicine and the Chao Family Comprehensive Cancer Center, Orange County, California

Fam-trastuzumab deruxtecan-nxki (Enhertu)

Approval type: Accelerated
Indication: 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
Month: April
To read more, visit: bit.ly/3OW93RA

"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.”

Ronan J. Kelly, MD, MBA
Baylor Scott & White Charles A. Sammons Cancer Center at Baylor University Medical Center, Dallas, Texas

Repotrectinib (Augtyro)

Approval type: Accelerated
Indication: Adult and pediatric patients 12 years and older with locally advanced or metastatic solid tumors harboring an NTRK 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
Month: June
To read more, visit:­ bit.ly/4gEWk1y

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

Approval type: Regular
Indication: 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)
Month: December
To read more, visit: bit.ly/4j10Fhl

Lifileucel

Approval type: Accelerated
Indication: Adults with unresectable or metastatic melanoma previously treated with a PD-1 antibody and, if BRAF V600 positive, a BRAF inhibitor with or without a MEK inhibitor
Month: February
To read more, visit: ­bit.ly/3P1gEhS

"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].”

Daniel Olson, MD
University of Chicago Medical Center, Illinois

Tovorafenib (Ojemda)

Approval type: Accelerated
Indication: For patients 6 months and older with relapsed or refractory low-grade glioma harboring a BRAF fusion or rearrangement, or a BRAF V600 mutation
Month: April
To read more, visit: bit.ly/4256wwe

"[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].”

Sarah E. S. Leary, MD, MS
Fred Hutchinson Cancer Research Center, Seattle, Washington

Selpercatinib

Approval type: Accelerated
Indication: Pediatric patients aged 2 or older who have advanced or metastatic
medullary thyroid cancer and a RET mutation who require systemic therapy; advanced or metastatic thyroid cancer with a RET 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 RET 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
Month: May
To read more, visit: bit.ly/3Dg8r6O

Selpercatinib

Approval type: Regular
Indication: Adult and pediatric patients at least 2 years of age with advanced or metastatic RET fusion–positive thyroid cancer who require systemic therapy and who are radioactive iodine refractory, if radioactive iodine is appropriate
Month: June
To read more, visit: bit.ly/41CWfXC

"This is a major landmark for patients with RET-driven cancers. The availability of selpercatinib for these patients can be life-changing; the efficacy rates with selpercatinib are very high, the durability of efficacy is long, and the safety profile is excellent. Selpercatinib is very well tolerated for most patients who need treatment, and the drug will be widely available.”

Lori Wirth, MD
Harvard Medical School and Massachusetts General Hospital, Boston

Afamitresgene autoleucel (Tecelra)

Approval type: Accelerated
Indication: Adult patients with unresectable or metastatic synovial sarcoma who have received prior chemotherapy; are HLA-A*02:01P, -A*02:02P, -A*02:03P, or -A*02:06P positive; and whose tumors express MAGE-A4, as determined by FDA-approved or -cleared companion diagnostic devices
Month: August
To read more, visit: bit.ly/3Dnl6EX

Vorasidenib (Voranigo)

Approval type: Regular
Indication: Adult and pediatric patients 12 years and older with grade 2 astrocytoma or oligodendroglioma with a susceptible IDH1 or IDH2 mutation following surgery, including biopsy, subtotal resection, or gross total resection
Month: August
To read more, visit: ­bit.ly/49IpZVd

"[This regulatory decision] represents the first approval [of a systemic] medication for patients with low-grade glioma in more than 20 years, and [vorasidenib] is the first truly targeted therapy for a large population of patients with glioma…. [This indication will] allow for careful conversations between patients and providers, but those will have to be thoughtful discussions.”

Seema Nagpal, MD
Stanford University, California

Selpercatinib

Approval type: Regular
Indication: Adult and pediatric patients 2 years and older with advanced or metastatic medullary thyroid cancer with a RET mutation, as detected by an FDA-approved test, who require systemic therapy
Month: September
To read more, visit: bit.ly/3ApuczR

Cosibelimab-ipdl (Unloxcyt)

Approval type: Regular
Indication: Adults with metastatic or locally advanced cutaneous squamous cell carcinoma who are not candidates for curative surgery or radiation
Month: December
To read more, visit: bit.ly/3ZUZOHs

Axatilimab-csfr (Niktimvo)

Approval type: Regular
Indication: Adult and pediatric patients weighing at least 40 kg with chronic graft-vs-host disease (cGVHD) who have progressed on at least 2 prior lines of systemic therapy
Month: August
To read more, visit: bit.ly/3BHkQjt

Subcutaneous atezolizumab and hyaluronidase-tqjs (Tecentriq Hybreza)

Approval type: Regular
Indication: All the same adult indications as the intravenous formulation of atezolizumab, including in NSCLC, SCLC, hepatocellular carcinoma, melanoma, and alveolar soft part sarcoma
Month: September
To read more, visit: bit.ly/3W6KzsX

Reference

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