February Roundup of FDA Approvals in Oncology: 6 Decisions to Know

Below is your guide to all the oncologic options that were given the green light by the FDA in February 2026. 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.

2/10: Pembrolizumab Plus Paclitaxel With/Without Bevacizumab in PD-L1+ Platinum-Resistant Ovarian Cancer

Indication: The FDA approved pembrolizumab (Keytruda) and pembrolizumab plus berahyaluronidase alfa-pmph (Keytruda Qlex) plus paclitaxel, with or without bevacizumab (Avastin), for use in adult patients with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal carcinoma whose tumors express PD-L1 (combined positive score [CPS] ≥ 1) and who have previously received 1 or 2 systemic treatment regimens.¹

Supporting data: The decision was supported by findings from the phase 3 KEYNOTE-B96 trial (NCT05116189). In patients with a PD-L1 CPS of 1 or higher (n = 466), pembrolizumab plus paclitaxel with or without bevacizumab improved median progression-free survival (PFS) to 8.3 months (95% CI, 7.0-9.4) vs 7.2 months (95% CI, 6.2-8.1) with placebo plus chemotherapy (HR, 0.72; 95% CI, 0.58-0.89; P = .0014) and improved median overall survival (OS) to 18.2 months (95% CI, 15.3-21.0) vs 14.0 months (95% CI, 12.5-16.1; HR, 0.76; 95% CI, 0.61-0.94; P = .0053).² The regulatory agency also cleared the PD-L1 IHC 22C3 pharmDx assay as a companion diagnostic to identify eligible patients.

Clinical significance: This approval introduces the first and only PD-1 inhibitor–based regimens for adults with PD-L1–positive platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal carcinoma.³ Historically, outcomes in this setting have been poor and therapeutic options limited once disease becomes platinum resistant.

“This is a historical moment in ovarian cancer because we had so many negative immuno-oncology [IO] clinical trials, and this is the first positive IO clinical trial and the first indication for pembrolizumab in ovarian cancer,” Emese Zsiros, MD, PhD, FACOG, told OncLive®.⁴ “Our field is extremely excited. This is not necessarily an easy regimen [to receive], because it requires weekly administration of paclitaxel, but the results are very strong and scientifically sound. It is exciting for us to see a significant and clinically meaningful OS benefit in this very challenging [to treat] patient population.”

OTHER RELATED COVERAGE

• Findings from the final analysis of KEYNOTE-B96 were shared during the 2026 European Society of Gynaecological Oncology Congress and showed that pembrolizumab and paclitaxel plus or minus bevacizumab significantly improved PFS and OS vs paclitaxel with or without bevacizumab alone, regardless of PD-L1 status, in patients with platinum-resistant ovarian cancer.
• In a past interview, Nicoletta Colombo, MD, PhD, of the European Institute of Oncology, IRCCS, University of Milan-Bicocca, discussed how unique aspects of the KEYNOTE-B96 trial design set it up for success where other chemoimmunotherapy trials have failed; reported findings from both the first and second interim analyses; and projected where the regimen might fit into the larger treatment armamentarium for platinum-resistant, recurrent ovarian cancer.

2/12: Optune Pax for Locally Advanced Pancreatic Cancer

Indication: The FDA cleared Optune Pax—a portable, noninvasive device that delivers tumor-treating fields (TTFields) to the abdomen to disrupt cancer cell division while minimizing damage to healthy tissue—for concomitant use with gemcitabine and nab-paclitaxel (Abraxane) in adult patients with locally advanced pancreatic cancer.^5,6

Supporting data: The decision was supported by findings from the phase 3 PANOVA-3 trial (NCT03377491). In the intention-to-treat population, the median OS was 16.2 months (95% CI, 15.0-18.0) with Optune Pax plus chemotherapy (n = 285) vs 14.2 months (95% CI, 12.8-15.4) with chemotherapy alone (n = 286; HR, 0.82; 95% CI, 0.68-0.99; P = .039). In the modified per protocol population, median OS was 18.3 (95% CI, 16.1-20.0) with Optune Pax (n = 198) vs 15.1 months (95% CI, 13.4-17.0) with the control (n = 207; HR, 0.77; 95% CI, 0.62-0.97; P = .023). The regimen also improved 1-year OS rates, time to pain progression, and quality-of-life (QOL) deterioration-free survival without increasing systemic toxicity. Device-related skin reactions were mostly mild (grade 1 or 2), and no unexpected safety signals were observed.

Clinical significance: This decision introduces a first-of-its-kind, noninvasive, TTField-based treatment option for patients with locally advanced pancreatic cancer. Optune Pax provides a way to extend survival and preserve quality of life while integrating into patients’ daily routines, marking a potential shift toward more personalized, outpatient-friendly management of this aggressive malignancy.

“PANOVA-3, in which the TTFields were tested, is really the first positive trial ever in this stage of pancreatic cancer, so it’s a historical landmark for that reason,” Vincent Picozzi, MD, of the Floyd & Delores Jones Cancer Institute at Virginia Mason Medical Center, told OncLive.

OTHER RELATED COVERAGE

• An exclusive gastrointestinal cancer roundup spotlights 8 pivotal pipeline updates from February in pancreatic cancer, gastric cancer, hepatocellular carcinoma, and more.

2/17: Monthly First-Line Amivantamab and Hyaluronidase Dosing in EGFR-Mutated, Advanced NSCLC

Indication: The FDA approved a simplified once-monthly dosing schedule of amivantamab and hyaluronidase-lpuj (Rybrevant Faspro; subcutaneous amivantamab) for first-line use in patients with EGFR-mutated, advanced non–small cell lung cancer (NSCLC). This update allows patients to transition to monthly dosing as early as week 5, replacing the previous schedule of weekly dosing for 4 weeks followed by dosing every 2 weeks.⁷

Supporting data: Data from the phase 2 PALOMA-2 trial (NCT05498428), which evaluated monthly subcutaneous amivantamab and hyaluronidase plus lazertinib (Lazcluze) in patients with previously untreated EGFR-mutated advanced NSCLC (n = 77), the investigator-assessed overall response rate (ORR) was 82% and the independent central review–assessed ORR was 87%; the confirmed ORRs in the respective groups were 79% and 83%.^8,9 The median duration of response (DOR), PFS, and OS were not reached at a median follow-up of 6.5 months. The regimen also showcased a lower rate of administration-related reactions vs historical intravenous data.

Clinical significance: This decision introduces a more convenient administration schedule for patients with EGFR-mutated NSCLC who are receiving amivantamab-based therapy, reducing treatment burden while maintaining comparable efficacy and safety.⁷ The shift to monthly subcutaneous dosing may improve patient experience, streamline clinic workflows, and support sustained use of the amivantamab/lazertinib regimen in the frontline setting.

2/20: First-Line Acalabrutinib Plus Venetoclax in CLL/SLL

Indication: The FDA cleared the combination of acalabrutinib (Calquence) and venetoclax (Venclexta) for the treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), providing a fixed-duration, frontline option for those without 17p deletions or TP53 mutations.^10,11

Supporting data: The decision was supported by findings from the phase 3 AMPLIFY trial (NCT03836261), which showed that at a median follow-up of 42.6 months, the median PFS was not estimable (NE; 95% CI, 51.1-NE) with acalabrutinib plus venetoclax (n = 291) in patients with previously untreated CLL without del(17p) or TP53 mutations vs 47.6 months (95% CI, 43.3-NE) with investigator’s choice of chemotherapy (n = 290), which could have been fludarabine plus cyclophosphamide plus rituximab FCR or bendamustine plus rituximab BR (HR, 0.65; 95% CI, 0.49-0.87; P = .0038).¹² Moreover, the ORRs reported in the respective arms were 93% (95% CI, 89%-95%) and 75% (95% CI, 70%-80%).

Clinical significance: This approval introduces the first all-oral, fixed-duration BTK inhibitor–based regimen for CLL/SLL in the US, offering patients an effective, time-limited therapy that may reduce treatment burden vs continuous regimens.¹⁰ The combination represents a flexible, convenient option for tailoring frontline therapy.

OTHER RELATED COVERAGE

• In a past interview, Kathleen A. Dorritie, MD, of University of Pittsburgh Medical Center Hillman Cancer Center, detailed differing care among patients with newly diagnosed CLL vs those with relapsed/refractory disease who have received multiple lines of therapy.
• In a recent Rapid Readout program, Alan Skarbnik, MD, of Novant Health Cancer Institute, highlighted interim data from AMPLIFY, highlighting the efficacy and safety of fixed-duration acalabrutinib plus venetoclax, with or without obinutuzumab (Gazyva), vs chemoimmunotherapy for treatment-naive CLL.
• In a past Peer Exchange program, a panel of experts discussed how the AMPLIFY trial evaluated acalabrutinib/venetoclax/obinutuzumab vs acalabrutinib/venetoclax as frontline therapy options, highlighting the impressive depth of response with both regimens while noting the additional toxicity profile associated with the triplet combination.

2/24: Encorafenib Plus Cetuximab/Chemotherapy in BRAF V600E+ mCRC

Indication: The FDA granted full approval to encorafenib (Braftovi) plus cetuximab (Erbitux) and fluorouracil-based chemotherapy for use in adult patients with metastatic colorectal cancer (mCRC) harboring a BRAF V600E mutation, as detected by an FDA-approved test.¹³

Supporting data: The decision was based on findings from the phase 3 BREAKWATER trial (NCT04607421), in which treatment-naive patients with BRAF V600E–mutant mCRC who received encorafenib plus cetuximab and mFOLFOX6 (arm B; n = 236), the median PFS was 12.8 months (95% CI, 11.2-15.9) vs 7.1 months (95% CI, 6.8-8.5) with mFOLFOX6, FOLFOXIRI, or CAPOX each with or without bevacizumab (arm C; n = 243; HR, 0.53; 95% CI, 0.41-0.68; P < .0001).¹⁴ The median OS in the respective arms were 30.3 months (95% CI, 21.7-NE) and 15.1 months (95% CI, 13.7-17.7; HR, 0.49; 95% CI, 0.38-0.63; P < .0001). The ORR in arm B was 61% (95% CI, 52%-70%) vs 40% (95% CI, 31%-49%) in arm C (P = .0008).

Clinical significance: The encorafenib combination is the only targeted regimen approved for first-line treatment of BRAF V600E–mutant mCRC.¹⁵ The statistically significant improvements in key outcomes reported in BREAKWATER, support encorafenib plus cetuximab with fluorouracil-based chemotherapy as a new standard of care, according to Pfizer.

OTHER RELATED COVERAGE

• Topline data from BREAKWATER were announced on February 17, 2026, and showed that encorafenib plus cetuximab and FOLFIRI significantly improved PFS vs standard FOLFIRI with or without bevacizumab in patients with previously untreated mCRC harboring a BRAF V600E mutation.
• Full BREAKWATER findings were shared during the 2026 Gastrointestinal Cancers Symposium and Scott Kopetz, MD, PhD, FACP, of The University of Texas MD Anderson Cancer Center, said that “BREAKWATER cohort 3 supports the option of FOLFIRI as a backbone in combination with EC as a potential new first-line standard of care for patients with BRAF V600E–mutant mCRC.”
• BREAKWATER was listed among the top data readouts to come out of the meeting. Sign up to read the exclusive recap article.
• In a past Peer Exchange program, a panel of experts explained how the BREAKWATER trial demonstrates that up-front treatment with encorafenib plus cetuximab significantly improves outcomes in BRAF V600E–mutated CRC, turning a historically poor prognostic marker into a targetable opportunity.

2/26: Zongertinib in Unresectable or Metastatic, Nonsquamous NSCLC With HER2 TKD Mutations

Indication: The FDA granted accelerated approval to zongertinib for the treatment of adult patients with unresectable or metastatic, nonsquamous NSCLC whose tumors harbor HER2 (ERBB2) tyrosine kinase domain (TKD) activating mutations, as detected by an FDA-authorized test.¹⁶

Supporting data: The regulatory decision was supported by findings from the phase 1 Beamion LUNG-1 trial (NCT04886804), which showed that in patients with HER2 TKD-mutant NSCLC (n = 72), the investigator-assessed objective response rate (ORR) was 76% (95% CI, 65%-85%); 64% of responders experienced a DOR of at least 6 months and 44% had a DOR of at least 12 months. The prescribing information includes warnings and precautions pertaining to hepatotoxicity, left ventricular dysfunction, interstitial lung disease or pneumonitis, and embryo-fetal toxicity.

Clinical significance: Zongertinib establishes a new standard as the first targeted therapy for treatment-naive patients with HER2-mutant advanced NSCLC.¹⁷ This approval marks a shift toward biomarker-driven care in this rare and aggressive NSCLC subtype, addressing a population historically underserved by standard therapies and highlighting the importance of precision medicine in lung cancer management.

“[Zongertinib] really quickly is becoming the first choice because of those favorable characteristics,” Balazs Halmos, MD, MS, of Albert Einstein College of Medicine, told OncLive.

OTHER RELATED COVERAGE

• In a recent interview for Biomarker Consortium, Eric K. Singhi, MD, of The University of Texas MD Anderson Cancer Center, discussed how to optimize therapy for HER2-mutated NSCLC with zongertinib.
• In a past Insights program, Jacob Sands, MD, of Dana-Farber Cancer Institute, detailed a case study on managing HER2-mutant NSCLC, highlighting treatment strategies like zongertinib after antibody-drug conjugate therapy. Julia Rotow, MD, also of Dana Farber, detailed another case study with zongertinib in this disease.
• On August 8, 2025, the FDA approved zongertinib, a highly selective HER2 tyrosine kinase inhibitor, based on earlier data from Beamion LUNG-1 study, which was designed to address this significant unmet need.
• In a past interview, Martin Dietrich, MD, PhD, of The US Oncology Network Cancer Care Centers of Brevard, discussed the meaningful clinical activity observed with zongertinib in both treatment-naive and previously treated patients with HER2-mutant NSCLC, highlighting the agent’s strong intracranial efficacy, durable responses, and favorable safety profile.

Other Noteworthy Decisions

• The FDA also approved an update to the prescribing information for axicabtagene ciloleucel (axi-cel; Yescarta), removing the prior Limitations of Use for patients with relapsed/refractory primary central nervous system lymphoma.¹⁸

References

1. FDA approves pembrolizumab with paclitaxel for platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal carcinoma. FDA. February 10, 2026. Accessed March 5, 2026. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-pembrolizumab-paclitaxel-platinum-resistant-epithelial-ovarian-fallopian-tube-or
2. Keytruda injection. Prescribing information. Merck Sharp & Dohme LLC; 2026. Accessed March 5, 2026. https://www.merck.com/product/usa/pi_circulars/k/keytruda/keytruda_pi.pdf
3. KEYTRUDA® (pembrolizumab) and KEYTRUDA QLEX™ (pembrolizumab and berahyaluronidase alfa-pmph), plus paclitaxel ± bevacizumab, approved for certain adults with PD-L1+ (CPS ≥1) platinum-resistant ovarian carcinoma as second or third line treatment. News release. Merck. February 11, 2026. Accessed March 5, 2026. https://www.merck.com/news/keytruda-pembrolizumab-and-keytruda-qlex-pembrolizumab-and-berahyaluronidase-alfa-pmph-plus-paclitaxel-%C2%B1-bevacizumab-approved-for-certain-adults-with-pd-l1-cps-%E2%89%A51/
4. Seymour C. KEYNOTE-B96 approval reinforces the shift toward biomarker-driven treatment in recurrent PROC: Q&A with Emese Zsiros, MD, PhD, FACOG. OncLive.com. March 5, 2026. https://www.onclive.com/view/keynote-b96-approval-reinforces-the-shift-toward-biomarker-driven-treatment-in-recurrent-proc
5. FDA approves first-of-its-kind device to treat pancreatic cancer. News release. FDA. February 12, 2026. Accessed March 5, 2026. https://www.fda.gov/news-events/press-announcements/fda-approves-first-its-kind-device-treat-pancreatic-cancer
6. US FDA approves Novocure’s Optune Pax for the treatment of locally advanced pancreatic cancer. News release. Novocure. February 11, 2026. Accessed March 5, 2026. https://www.novocure.com/us-fda-approves-novocures-optune-paxr-treatment-locally-advanced-pancreatic-cancer
7. FDA approves Rybrevant Faspro (amivantamab and hyaluronidase-lpuj) as the only EGFR-targeted therapy that can be administered once a month. News release. Johnson & Johnson. February 17, 2026. Accessed March 5, 2026. https://www.investor.jnj.com/investor-news/news-details/2026/FDA-approves-RYBREVANT-FASPRO-amivantamab-and-hyaluronidase-lpuj-as-the-only-EGFR-targeted-therapy-that-can-be-administered-once-a-month/default.aspx
8. Leighl NB, Akamatsu H, Lim SM, et al. Subcutaneous amivantamab vs intravenous amivantamab, both in combination with lazertinib, in refractory EGFR-mutated, advanced non-small cell lung cancer (NSCLC): primary results, including overall survival (OS), from the global, phase 3, randomized controlled PALOMA-3 trial. J Clin Oncol. 2024;42(suppl 17):LBA8505. doi:10.1200/JCO.2024.42.17_suppl.LBA8505
9. PALOMA-2 study: subcutaneous amivantamab every 4 weeks plus lazertinib shows high response rate in EGFR-mutated NSCLC. News release. International Association for the Study of Lung Cancer. September 9, 2025. Accessed March 5, 2026. https://www.iaslc.org/iaslc-news/press-release/paloma-2-study-subcutaneous-amivantamab-every-4-weeks-plus-lazertinib
10. Calquence plus venetoclax approved in the US as first all-oral, fixed-duration combination for patients with chronic lymphocytic leukaemia in the 1st-line setting. News release. AstraZeneca. March 5, 2026. Accessed February 20, 2026. https://www.astrazeneca.com/media-centre/press-releases/2026/fixed-duration-calquence-combo-approved-in-us.html
11. FDA approves acalabrutinib with venetoclax for chronic lymphocytic leukemia or small lymphocytic lymphoma. FDA. February 19, 2026. Accessed March 5, 2026. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-acalabrutinib-venetoclax-chronic-lymphocytic-leukemia-or-small-lymphocytic-lymphoma
12. Calquence. Prescribing information. AstraZeneca; February 2026. Accessed March 5, 2026. https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/210259s012lbl.pdf
13. FDA grants traditional approval to encorafenib for metastatic colorectal cancer with a BRAF V600E mutation. FDA. February 24, 2026. Accessed March 5, 2026. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-traditional-approval-encorafenib-metastatic-colorectal-cancer-braf-v600e-mutation
14. Braftovi. Prescribing information. Pfizer, Inc; February 2026. Accessed March 5, 2026. https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/210496s021lbl.pdf
15. US FDA grants full approval to Pfizer’s Braftovi combination regimen in first-line metastatic colorectal cancer. News release. Pfizer. February 24, 2026. Accessed March 5, 2026. https://www.pfizer.com/news/press-release/press-release-detail/us-fda-grants-full-approval-pfizers-braftovi-combination
16. FDA grants accelerated approval to zongertinib for unresectable or metastatic non-squamous non-small cell lung cancer. FDA. February 26, 2026. Accessed March 5, 2026. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-zongertinib-unresectable-or-metastatic-non-squamous-non-small-cell
17. FDA approves HERNEXEOS®, the first targeted therapy for adults with HER2-mutant advanced NSCLC as an initial treatment option. News release. Boehringer Inhelheim. February 26, 2026. Accessed March 5, 2026. https://www.boehringer-ingelheim.com/human-health/cancer/lung-cancer/fda-approves-hernexeos-first-line-lung-cancer
18. FDA approves label update for Kite’s Yescarta for relapsed/refractory primary central nervous system lymphoma. News release. Kite, a Gilead Company. February 06, 2026. Accessed March 5, 2026. https://www.kitepharma.com/news/press-releases/2026/2/fda-approves-label-update-for-kites-yescarta-for-relapsedrefractory-primary-central-nervous-system-lymphoma