OncLive’s November Roundup of Key FDA Approvals in Oncology: 10 Decisions to Know

Below is your guide to all the oncologic options that were approved by the FDA in November 2025. The regulatory roundup provides everything you need to know, right at your fingertips—all the topline data that supported the decisions and expert insights detailing clinical practice implications.

11/6: Subcutaneous Daratumumab in High-Risk Smoldering Multiple Myeloma

Indication: The FDA approved daratumumab and hyaluronidase-fihj (Darzalex Faspro) for the treatment of adult patients with high-risk smoldering multiple myeloma (HR-SMM).

Supporting data: The regulatory decision was supported by data from the phase 3 AQUILA trial (NCT03301220). At a median follow-up of 63.1 months, subcutaneous daratumumab (n = 194) reduced the risk of progression or death by 51% vs active monitoring (n = 196); the median progression-free survival (PFS) was not reached (NR) with daratumumab vs 41.5 months with observation (HR, 0.49; 95% CI, 0.36-0.67; P < .001). Moreover, findings from a post-hoc analysis indicated that among patients who met Mayo 2018 HR-SMM classification, the median PFS was NR with daratumumab vs 22.1 months with active monitoring (HR, 0.36; 95% CI, 0.23-0.58). Lastly, daratumumab also led to a higher response rate vs observation, at 63.4% vs 2.0% (P < .001). Safety data proved consistent with what has been reported with subcutaneous daratumumab. The most common treatment-emergent adverse effects were upper respiratory tract infection, musculoskeletal pain, fatigue, diarrhea, and rash, among others.

Clinical significance: Subcutaneous daratumumab represents the first approved option for patients with HR-SMM, enabling earlier intervention before progression to active disease. The AQUILA data establish daratumumab as a new option for delaying symptomatic disease in a population where half of patients typically progress within 2 years.

“This [FDA approval] is a critical first step, but there are a lot of questions that remain. Is there a more aggressive strategy or preferred approach for patients [than] daratumumab monotherapy? We are going to have to do randomized studies to show whether that is the case,” Peter Voorhees, MD, of Wake Forest University School of Medicine and Atrium Health Levine Cancer Institute, said in an exclusive interview with OncLive®. “It is a really exciting space, and it will be really interesting to see how this evolves in the years ahead.”

OTHER RELATED COVERAGE

• In the full interview, Voorhees expanded on how the approval might change treatment processes for patients with HR-SMM and indicated the significance of the regulatory decision, in addition to addressing the trial itself and its common criticisms.
• AQUILA data were shared during the 2025 SOHO Annual Meeting. Authors of the poster wrote, “Results from the phase 3 AQUILA study strongly support early intervention with subcutaneous [daratumumab] monotherapy for a fixed duration in patients with high-risk [smoldering multiple myeloma], representing an opportunity to delay or avoid end-organ damage and progression to [multiple myeloma] while preserving quality of life and extending survival.”
• Previously, in May 2025, the FDA’s Oncologic Drugs Advisory Committee voted 6 to 2 in favor of the risk/benefit profile of subcutaneous daratumumab as monotherapy for patients with HR-SMM, based on AQUILA trial data. During the meeting, the FDA questioned the applicability of the AQUILA findings to this population. “In clinical practice, there’s some flexibility about how high risk is defined, as all definitions have been found to lead to similar outcomes,” Sagar Lonial, MD, FACP, of the Winship Cancer Institute of Emory University said. “The PFS curve…for the control arm is consistent with a high-risk smoldering myeloma group, no matter what definition you use.”

11/7: Generic Dasatinib Tablets in CML and ALL

Indication: The FDA granted final approval to generic dasatinib tablets (20 to 140 mg), which are therapeutically equivalent to the reference drug (Sprycel). Indications are in adult and pediatric patients with Philadelphia chromosome (Ph)–positive chronic myeloid leukemia (CML) and acute lymphoblastic leukemia (ALL), including use in combination with chemotherapy for pediatric Ph-positive ALL.

Supporting data: Dasatinib was initially cleared by the agency in 2006, and the most recent approval was in January 2019 where dasatinib was indicated for use in combination with chemotherapy in pediatric patients at least 1 year of age who had Ph-positive ALL. That decision was based on data from the phase 2 CA180-372 trial (NCT01460160), which showed that pediatric patients with newly diagnosed B-cell precursor Ph-positive ALL (n = 78) experienced a 3-year event-free survival rate of 64.1% (95% CI, 52.4%-74.7%). At the end of induction and consolidation therapy, 96% and 97% of patients, respectively, achieved a bone marrow blast percentage below 5%. Toxicities led to treatment discontinuation for 10% of patients, and serious adverse effects (AEs) included pyrexia, febrile neutropenia, mucositis, and diarrhea.

Clinical significance: The approval of generic dasatinib provides a therapeutically equivalent, potentially more accessible option to the brand product for patients with Ph-positive CML and ALL across adult and pediatric populations, supporting broader availability of an established standard-of-care therapy.

11/13: Ziftomenib in NPM1+ Relapsed/Refractory Acute Myeloid Leukemia

Indication: The FDA approved ziftomenib (Komzifti) for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with a susceptible NPM1 mutation who lack satisfactory alternative therapeutic options.

Supporting data: The decision was based on findings from the phase 1/2 KOMET-001 trial (NCT04067336), in which ziftomenib, when given at a once-daily dose of 600 mg (n = 112), elicited a complete remission (CR) plus CR with full or partial hematologic recovery (CRh) rate of 21.4% (95% CI, 14.2%-30.2%) at a median follow-up of 4.2 months (range, 0.1-41.2); the median duration of CR+CRh was 5.0 months. Moreover, 21.2% of the 66 patients who were dependent on red blood cell and/or platelet transfusions during any 56-day post-baseline period achieved independence. Of those who were independent of both RBC and platelet transfusions at baseline (n = 46), 26.1% remained independent. Prescribing information includes warnings and precautions for QTc interval prolongation, differentiation syndrome, and embryo-fetal toxicity.

Clinical significance: Ziftomenib represents the first and only once-daily targeted therapy for patients with NPM1-mutated AML, a population with historically poor outcomes and limited options. Its targeted mechanism, oral convenience, and manageable toxicity profile allow integration into care for those who are often older and not able to receive intensive chemotherapy.

“[Ziftomentib] addresses a critical need for adult patients with [relapsed/refractory] NPM1-[mutated] AML, many of whom are older and unable to tolerate intensive chemotherapy or transplant,” Eunice Wang, MD, chief of the Leukemia Service and professor of oncology at Roswell Park Comprehensive Cancer Center, stated in a news release. “The clinical data demonstrate deep and durable responses with a manageable safety profile, including no drug-drug interactions and no Boxed Warnings for QTc prolongation or Torsades de Pointes— key advantages for patients on multiple concurrent medications. This approval equips physicians with a new oral therapy to integrate into care and improve outcomes for this vulnerable patient population.”

OTHER RELATED COVERAGE

• In a recent podcast episode of OncLive On Air, Harry P. Erba, MD, PhD, of Duke University School of Medicine and Duke Cancer Institute, discussed the significance of the approval, key efficacy and safety findings from KOMET-001, and the role ziftomenib may play throughout the evolution of the AML treatment paradigm.
• In a prior interview, Amir Fathi, MD, of Massachusetts General Hospital and Harvard Medical School, discussed KOMET-001 data.
• In November 2025, the National Comprehensive Cancer Network (NCCN) updated its Clinical Practice Guidelines in Oncology for AML to include ziftomenib as a category 2A recommendation for the treatment of patients with relapsed or refractory AML harboring an NPM1 mutation.

11/18: Epcoritamab in Relapsed/Refractory Follicular Lymphoma

Indication: The regulatory agency cleared epcoritamab-bysp (Epkinly) for use in combination with rituximab (Rituxan) and lenalidomide (Revlimid) in adult patients with relapsed or refractory follicular lymphoma. The FDA also granted traditional approval to single-agent epcoritamab for the treatment of patients who have previously received at least 2 lines of therapy.

Supporting data: Approval of the triplet regimen was based on data from the phase 3 EPCORE FL-1 trial (Study M20-638; NCT05409066), which met its coprimary end points of overall response rate (ORR) and PFS. Specifically, the combination (n = 243) reduced the risk of disease progression or death by 79% vs rituximab plus lenalidomide alone (n = 245; HR, 0.21; 95% CI, 0.13-0.33; P < .0001). In the respective arms, the median PFS was NR (95% CI, 21.9-NR) and 11.2 months (95% CI, 10.5-NR). Moreover, the respective ORRs were 89% (95% CI, 84%-93%) and 74% (95% CI, 68%-79%). The safety profile was consistent with known effects of the individual agents. The prescribing information includes boxed warnings for cytokine release syndrome (CRS) and immune effector cell–associated neurotoxicity syndrome.

Clinical significance: This approval marks the first and only bispecific antibody combination available to patients with relapsed or refractory follicular lymphoma after at least 1 line of systemic therapy; because the regimen is chemotherapy free and can be given in the outpatient setting, it possesses the potential to become a new standard of care (SOC).

“Recurrent follicular lymphoma can be an incurable, complex, and persistent disease, creating a clear need for additional treatments that can change its course earlier in the treatment journey,” Lorenzo Falchi, MD, of Memorial Sloan Kettering Cancer Center, stated in a news release. “The results shown with [the epcoritamab combination] in the EPCORE FL-1 study are incredibly meaningful, demonstrating durable responses compared to patients treated with [lenalidomide/rituximab] alone. These data, delivered by a regimen that's chemotherapy-free and can be administered in the outpatient setting, suggest that [the combination] could potentially become a new standard of care."

OTHER RELATED COVERAGE

• In August 2025, Genmab announced that EPCORE FL-1 met its dual primary end points of ORR and PFS in this patient population.
• In a past Rapid Readouts program, Falchi further unpacked the EPCORE FL-1 trial, providing background on the disease, the mechanism of action of epcoritamab, the design of the trial, and the unmet need it would address.

11/19: Selumetinib in NF1-Associated Plexiform Neurofibromas

Indication: The FDA cleared selumetinib (Koselugo) for the treatment of adult patients with neurofibromatosis type 1 (NF1) who have symptomatic, inoperable plexiform neurofibromas (PN).

Supporting data: The decision was based on findings from the phase 3 KOMET trial (NCT04924608), in which selumetinib (n = 71) elicited a confirmed ORR of 20% (95% CI, 11%-31%) compared with 5% (95% CI, 2%-13%) with placebo (n = 74; P = .011). The median duration of response (DOR) was NR (95% CI, 11.5-not evaluable [NE]) with selumetinib, and the 6-month DOR rate was 86%. Patients also showed consistent improvements in chronic pain and reduced use of pain medications. Prescribing information comprises warnings and precautions for ocular toxicity, left ventricular dysfunction, gastrointestinal (GI) and skin toxicity, increased creatinine phosphokinase, increased levels of vitamin E, and increased risk of bleeding, along with embryo-fetal toxicity.

Clinical significance: Selumetinib is the first FDA-approved therapy for adult patients with NF1-related symptomatic, inoperable PN, addressing a rare, progressive disease with high morbidity. It provides a targeted, oral option that can reduce tumor burden, improve pain, and offer continuity of care from pediatric to adult treatment, transforming the SOC for this underserved population.

“The KOMET phase 3 trial, which builds on the established clinical profile of [selumetinib] and its real-world use in pediatric patients, underscores its potential to address the substantial and oftentimes progressive clinical burdens associated with PN in adulthood,” Professor Pierre Wolkenstein, MD, PhD, of Henri Mondor Hospital, APHP, Paris East University, stated in a news release. “This approval reaffirms the role of [selumetinib] as a strong option for the treatment of adult and pediatric patients with NF1 PN.”

OTHER RELATED COVERAGE

• In October 2025, selumetinib was cleared in the European Union for the management of symptomatic, inoperable PNs in adult patients with NF1 based on KOMET data.
• In a past OncLive On Air podcast episode, Christopher L. Moertel, MD, of the University of Minnesota School of Medicine, discussed the expansion of the NF1-associated PN treatment paradigm to include the MEK inhibitors selumetinib and mirdametinib (Gomekli), the benefits of offering options in oral formulations, the toxicities associated with MEK inhibitors, and more.

11/19: Subcutaneous Daratumumab in Newly Diagnosed Light Chain Amyloidosis

Indication: The regulatory agency awarded traditional approval to daratumumab and hyaluronidase-fihj (Darzalex Faspro) paired with bortezomib (Velcade), cyclophosphamide, and dexamethasone (D-VCd) for the treatment of adult patients with newly diagnosed light chain (AL) amyloidosis.

Supporting data: The decision was based on findings from the phase 3 ANDROMEDA trial (NCT03201965), which demonstrated that D-VCd (n = 195) improved hematologic CR (HemCR) with VCd alone, at 42% and 13%, respectively (P < .0001) and major organ deterioration–PFS (MOD-PFS; HR, 0.58; 95% CI, 0.37-0.92). After a median follow-up of 61.4 months, median MOD-PFS was not reached with D-VCd vs 30.2 months with VCd (HR, 0.47; 95% CI, 0.33-0.67; P < .0001). The median time to HemCR was 59 days (range, 8-299) with D-VCd, and the median duration of Hem CR was NR. D-VCd also led to a 38% reduction in the risk of death vs VCd (HR, 0.62; 95% CI, 0.42-0.90; P = .0121). Prescribing information includes warnings and precautions for cardiac toxicity, hypersensitivity, and other administrative reactions, neutropenia, thrombocytopenia, embryo-fetal toxicity, and interference with cross-matching and RBC antibody screening.

Clinical significance: D-VCd represents the first FDA-approved quadruplet regimen for newly diagnosed AL amyloidosis, providing a more effective option to achieve deep hematologic and organ responses. This regimen improves survival outcomes in a disease with a historically poor prognosis and addresses a critical need for early, aggressive therapy to prevent organ deterioration.

OTHER RELATED COVERAGE

• D-VCd was awarded accelerated approval from the FDA for this population in January 2021 based on earlier ANDROMEDA data.

• Jonathan L. Kaufman, MD, of Winship Cancer Institute at Emory University, previously discussed the significance of the decision in an exclusive interview: “This provides us with, for the first time, a proven single standard of care for patients with newly diagnosed AL amyloidosis, [except for] those who have significant cardiac involvement; those patients were excluded from the study. We still need to spend time and energy figuring out what the best therapy [is for those patients]. However, for all other patients, we can say the current standard of care is subcutaneous D-VCd. This is really going to call into question the role of autologous transplant in amyloidosis. We will probably see a significant decline in the use of transplant over the next several years.”
• In June 2021, the European Commission granted marketing authorization to D-VCd in adult patients with newly diagnosed systemic light chain amyloidosis based on ANDROMEDA.
• In a prior Rapid Readouts program, Raymond L. Comenzo, MD, of Tufts Medical Center, further unpacked results from ANDROMEDA.

11/19: Tarlatamab in Extensive-Stage Small Cell Lung Cancer

Indication: The FDA awarded traditional approval to tarlatamab-dlle (Imdelltra) for the treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC) who have progressed on or following platinum-based chemotherapy.

Supporting data: The decision was supported by data from the phase 3 DeLLphi-304 trial (NCT05740566), in which tarlatamab improved median overall survival (OS) to 13.6 months s 8.3 months with SOC chemotherapy (HR 0.60; 95% CI, 0.47-0.77; P < .001). Moreover, the median PFS in the respective arms was 4.2 months vs 3.2 months (HR 0.72; 95% CI, 0.59-0.88; P < .001), and the ORRs were 35% and 20% with median durations of 6.9 and 5.5 months. Patient-reported outcomes showed greater improvement in dyspnea and cough with tarlatamab. Grade 3 or higher treatment-related AEs were less frequent with tarlatamab (27%) than with chemotherapy (62%). CRS occurred in 60% of monitored patients, but cases were mostly grade 1 or 2 in severity.

Clinical significance: Tarlatamab represents the first FDA-approved bispecific T-cell engager for ES-SCLC in the post-platinum setting, offering a targeted immunotherapy option with meaningful survival benefit, improved tolerability, and potential quality-of-life improvements vs chemotherapy.

“After years of research efforts, DeLLphi-304 was the first global phase 3 trial to demonstrate a significant survival benefit over chemotherapy in its setting, leading to NCCN Guidelines Category 1 status for tarlatamab and further demonstrating the validity of this treatment approach in small cell lung cancer,” Charles M. Rudin, MD, PhD, of Memorial Sloan Kettering Cancer Center, stated in a news release. “Importantly, data from DeLLphi-304 reflected in today’s approval also equip physicians with a greater understanding of managing treatment with bispecific T-cell engager therapy.”

OTHER RELATED COVERAGE

• Tarlatamab was initially granted accelerated approval for this indication in May 2024 based on data from the phase 2 DeLLphi-301 trial (NCT05060016). Here, the agent elicited an ORR of 40% (95% CI, 31%-51%) with a median DOR of 9.7 months (range, 2.7-20.7+).
• In a previous exclusive interview, Taofeek Owonikoko, MD, PhD, of the University of Maryland Marlene and Stewart Greenebaum Cancer Center and the University of Maryland Medical Center, discussed the significance of the decision.

11/19: Sevabertinib in HER2-Mutated Nonsquamous NSCLC

Indication: The FDA has granted accelerated approval to sevabertinib (Hyrnuo) for use in adult patients with locally advanced or metastatic nonsquamous non–small cell lung cancer (NSCLC) harboring HER2 (ERBB2) tyrosine kinase domain (TKD) activating mutations, who have previously received systemic therapy.

Supporting data: The approval was based on results from the phase 1/2 SOHO-01 trial (NCT05099172). In patients with HER2 TKD mutations who were previously treated but naive to HER2-targeted therapy (n = 70), sevabertinib induced an ORR of 71% (95% CI, 59%-82%) with a median DOR of 9.2 months (95% CI, 6.3-15.0). Those previously treated, including with prior HER2-targeted antibody-drug conjugates (n = 52), experienced an ORR of 38% (95% CI, 25%-53%) and a median DOR of 7.0 months (95% CI, 5.6-NE). Safety data indicated that the most common AEs reported with sevabertinib were diarrhea, rash, paronychia, stomatitis, and nausea. Serious AEs occurred in 31% of patients, and 3.7% experienced AEs that resulted in permanent discontinuation of the agent.

Clinical significance: Sevabertinib represents the first FDA-approved HER2-selective TKI for previously treated HER2-mutated NSCLC, offering high response rates, durable efficacy, and an oral, targeted therapy option for this molecularly defined population. Its approval addresses a critical unmet need in patients with HER2-mutant NSCLC, a subgroup historically lacking effective targeted treatments.

“We were able to show very good response rate [with sevabertinib] regardless of prior lines of therapy,” Xiuning Le, MD, PhD, of The University of Texas MD Anderson Cancer Center, said in an exclusive interview with OncLive during the 2025 ESMO Congress. “Overall, we think that this agent is very promising as a new option for patients with HER2-mutant lung cancer.”

OTHER RELATED COVERAGE

• The agency also cleared the Ion Torrent Oncomine Dx Target Test for use as a companion diagnostic to identify patients with NSCLC and select HER2 (ERBB2) TKD activating mutations who are eligible to receive sevabertinib.
• Full SOHO-01 data shared during the congress showed that single-agent sevabertinib elicited durable responses across treatment settings in this population.
• In a Rapid Readouts program, Martin Dietrich, MD, PhD, of US Oncology Network and Cancer Care Centers of Brevard, presented insights from an exploratory analysis of SOHO-01, unpacking how clinical and molecular factors impact treatment outcomes with sevabertinib.

11/21: Perioperative Enfortumab Vedotin Plus Pembrolizumab in Cisplatin-Ineligible MIBC

Indication: The FDA cleared enfortumab vedotin-ejfv (Padcev) plus pembrolizumab (Keytruda) or pembrolizumab and berahyaluronidase alfa-pmph (Keytruda Qlex) as neoadjuvant treatment followed by adjuvant therapy following cystectomy for patients with muscle-invasive bladder cancer (MIBC) who are not eligible for cisplatin.

Supporting data: The regulatory decision was supported by data from the phase 3 EV-303/KEYNOTE-905 trial (NCT03924895), which showed that perioperative enfortumab vedotin plus pembrolizumab (n = 170) significantly improved event-free survival (EFS) vs radical cystectomy plus pelvic lymph node dissection (RC + PLND) alone (n = 174). Specifically, the median EFS was NR (95% CI, 37.3-NR) vs 15.7 months (95% CI, 10.3-20.5) in the respective arms (HR, 0.40; 95% CI, 0.28-0.57; P < .0001). The median OS also favored the combination (HR, 0.50; 95% CI, 0.33-0.74; P = .0002). Safety was consistent with known profiles, although higher rates of grade 3 or higher AEs and treatment discontinuation were observed with the combination vs surgery alone.

Clinical significance: This approval represents the first FDA-approved perioperative regimen for cisplatin-ineligible MIBC, offering a non–platinum-based approach that substantially improves EFS and OS. The combination establishes a new standard for perioperative care in this population.

“Enfortumab vedotin plus pembrolizumab is poised to address a critical unmet need. Half of patients with MIBC may experience cancer recurrence even after having their bladder removed, and many of these patients are ineligible to receive cisplatin,” Matthew Galsky, MD, of Mount Sinai Tisch Cancer Center, stated in a news release. “This approval, based on striking event-free and overall survival benefits, may represent an important practice-changing advance for these patients who’ve had no new options in decades.”

OTHER RELATED COVERAGE

• In a recent OncLive On Air podcast episode, the Two Onc Docs, Samantha A. Armstrong, MD, and Karine Tawagi, MD, reviewed updates on bladder cancer management from the 2025 ESMO Congress that they felt may change guidelines, including KEYNOTE-905 data.
• In a recent exclusive interview, Daniel P. Petrylak, MD, of Yale School of Medicine, explained how findings from KEYNOTE-905 and IMvigor011 (NCT04660344) presented during the 2025 ESMO Congress have the potential to alter the MIBC treatment paradigm. “To me, [KEYNOTE-905] is the most important study that came out of ESMO,” he said. “[These data] showed that this [regimen] is going to be the new standard of care for neoadjuvant therapy. We’ve never had neoadjuvant therapy in the past for cisplatin-ineligible patients.”

11/25: Perioperative Durvalumab in Resectable Gastric/GEJ Adenocarcinoma

Indication: The FDA cleared durvalumab (Imfinzi) plus FLOT (fluorouracil, leucovorin, oxaliplatin, and docetaxel) as neoadjuvant and adjuvant therapy, followed by durvalumab monotherapy, for use in adult patients with resectable gastric and gastroesophageal junction (GEJ) adenocarcinoma.

Supporting data: The decision was based on results from the phase 3 MATTERHORN trial (NCT04592913), which showed that durvalumab plus FLOT (n = 474) reduced the risk of disease progression, recurrence, or death by 29% compared with FLOT alone (n = 474; HR, 0.71; 95% CI, 0.58-0.86; P < .001). Specifically, the median EFS was NR (95% CI, 40.7-NE) with durvalumab vs 32.8 months (95% CI, 27.9-NE) with FLOT alone. The hazard ratio for OS was 0.78 (95% CI, 0.63-0.96; P = .021). Lastly, the pathological complete response (pCR) rate was higher with durvalumab vs without, at 19.2% (95% CI, 15.7%-23.0%) and 7.2% (95% CI, 5.0%-9.9%), respectively (P < .001). Safety was consistent with known profiles, with grade 3/4 AEs occurring in approximately 72% of patients.

Clinical significance: This decision establishes durvalumab plus FLOT as a perioperative SOC for resectable gastric and GEJ adenocarcinoma, offering improved EFS and higher pCR rates. The combination provides a new immunotherapy-based approach in the curative-intent setting, reinforcing the benefit of integrating checkpoint inhibition with chemotherapy in high-risk, resectable GI tumors.

“Today’s approval marks the first immunotherapy regimen approved in the neoadjuvant setting for gastric and gastroesophageal junction cancers—with durvalumab demonstrating a clear overall survival benefit and opening an entirely new chapter in the treatment of early-stage disease,” Yelena Y. Janjigian, MD, of Memorial Sloan Kettering Cancer Center, stated in a news release. “Nearly seven in 10 patients were alive at three years following treatment with the durvalumab-based perioperative regimen. This survival benefit, observed regardless of PD-L1 status, establishes a new standard of care in this curative-intent setting.”

OTHER RELATED COVERAGE

• MATTERHORN data were shared at the 2025 ESMO Congress and showed that the durvalumab combination provided a significant OS benefit vs placebo plus FLOT in this population. “The OS results of the MATTERHORN study strongly support the use of durvalumab plus chemotherapy with FLOT as a new global standard of care for patients with localized, [resectable, G/GEJ] adenocarcinoma,” Josep Tabernero, MD, of Vall d’Hebron University Hospital and Vall d’Hebron Institute of Oncology, said in the presentation.
• MATTERHORN was also featured in our dynamic video recap of the key GI cancer data updates from the congress, which included insights from James J. Harding, MD, of Memorial Sloan Kettering Cancer Center, and Jaume Capdevila, MD, Vall d’Hebron Hospital and Institute of Oncology Hospital Quirónsalud Barcelona.
• In a recent Rapid Readouts program, Janjigian and Zev A. Wainberg, MD, of UCLA Health, discussed key gastric cancer data shared at the 2025 ESMO Congress, including MATTERHORN.

Other Noteworthy Decisions

• The FDA cleared pertuzumab-dpzb (Poherdy) as an interchangeable biosimilar to the reference drug pertuzumab (Perjeta) across several indications in HER2-positive breast cancer.
• The regulatory agency also approved denosumab-desu (Osvyrti) and denosumab-desu (Jubereq) in all the same indications as the biosimilars referencing denosumab (Prolia; Xgeva), respectively.
• The FDA awarded approval to the Promega OncoMate® MSI Dx Analysis System as a companion diagnostic to identify patients with microsatellite stable (MSS) endometrial carcinoma who could be appropriate candidates for treatment with pembrolizumab plus lenvatinib (Lenvima).

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