5 FDA Developments From February: Kinase Inhibitors, GLP-1s, and a New Approval Pathway

The FDA approved numerous drugs across a wide range of diseases throughout the month of February—many of which were in the same drug class but for different indications. Additionally, the approval of novel portable devices that administer treatment could enable home-based care, therefore expanding access.

Here are 5 developments—drug and device approvals, pathways, and restrictions—the FDA announced last month.

1. Kinase Inhibitors and Targeted Therapies

Zognertinib (Hernexeos; Boehringer Ingelheim), a tyrosine kinase inhibitor (TKI), was approved to treat adults with unresectable or metastatic nonsquamous non–small cell lung cancer (NSCLC) whose tumors have HER2 tyrosine kinase domain–activating mutations. ¹

This approval expands on the previous approval of the drug to treat patients with HER2-mutatnt NSCLC who underwent systemic therapy. The original approval was based on findings from the Beamion LUNG-1 (NCT04886804) single-arm, open-label, multicenter, multicohort trial data presented at the 2024 World Conference on Lung Cancer and the 2025 American Association of Cancer Research (AACR) Annual Meeting.

The overall response rate was 76% (95% CI, 65%-85%); 64% of patients experienced a duration of response (DOR) of at least 6 months, and 44% had a DOR of at least 12 months.

“It’s very exciting for the first time to have an oral drug where the majority of patients are responding,” lead study author John V. Heymach, MD, PhD, said in an interview with The American Journal of Managed Care^® (AJMC^®) at the 2025 AACR Annual Meeting. “They’re having durable responses, and the toxicity for this drug is very limited; the safety profile is very manageable.”¹

Another kinase inhibitor approved last month was acalabrutinib (Calquence; AstraZeneca), a Bruton tyrosine kinase inhibitor, in combination with venetoclax (Vencelxta; AbbVie), a BCL-2 inhibitor. The combination therapy is the first and only all-oral fixed-dose combination treatment for chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL) or any other hematologic cancer.²

The findings were based on data from the phase 3 AMPLIFY trial (NCT03836261) that showed even after 3 years, 77% of patients who received the combination therapy did not experience disease progression. The risk of death was also reduced overall by 35% compared with the control group (HR, 0.65; 95% CI, 0.49-0.87; P = .0038).

“[The] Calquence combination offers patients an all-oral, 14-month, fixed-duration treatment option that is highly effective and well-tolerated and gives physicians greater flexibility to tailor treatment plans for individual patient needs and goals,” Jennifer Brown, MD, PhD, principal investigator of the AMPLIFY trial, said in a statement.²

2. Chemotherapies and Chemo-Based Regimens

Encorafenib in combination with cetuximab and fluorouracil-based chemotherapy (Braftovi; Array BioPharma) was approved to treat adult patients with metastatic colorectal cancer (CRC) who have the BRAF V600E mutation.³

The decision was based on findings from the BREAKWATER trial (NCT04607421), a randomized, open-label, multicenter study specifically for patients with CRC with that mutation. The trial randomized 479 patients into 2 arms, B and C, with arm C as the control arm. Patients in arm B received encorafenib orally once daily with cetuximab intravenously every 2 weeks and the modified FOLFOX-6 chemotherapy regimen.

The median progression-free survival (PFS) was 12.8 months (95% CI, 11.2-15.9) in arm B and 7.1 (95% CI, 6.8-8.5) months in arm C (HR, 0.53; 95% CI, 0.41-0.68; P < .0001). The median overall survival (OS) in arm B was nearly twice that of arm C (HR, 0.49; 95% CI, 0.38-0.63; P < .0001), with objective response rates of 61% and 40% (95% CI, 31%-49%; P = .0008), respectively.³

Also, a first-in-class portable device that delivers tumor-treating fields (TTFields) to the abdomen was approved in adult patients with locally advanced pancreatic cancer.⁴

The device Optune Pax (Novocure) was approved to administer gemcitabine and nab-paclitaxel (Abraxane; Bristol Myers Squibb). It delivers TTFields by alternating electrical fields to the abdomen through electrically insulated adhesive patches on the patient’s skin. The TTFields then physically disrupt the rapid cell proliferation of cancer cells while minimizing damage to healthy tissue.

The findings supporting approval were from the controlled phase 3 PANOVA-3 study (NCT03377491) that included 571 adult patients. The results showed that in concomitant use with chemotherapy, TTFields improved OS by 2 months (HR, 0.82; 95% CI, 0.68-0.99; P = .039) compared with those who only received the chemotherapy.⁴

3. Monoclonal Antibodies and Biologic Therapies

Dupilumab (Dupixent; Regeneron/Sanofi), a monoclonal antibody immunotherapy, was approved to treat adults and pediatric patients 6 years and older with allergic fungal rhinosinusitis (AFRS) who also have a history of sinonasal surgery.⁵

The decision was based on data from the phase 3 LIBERTY-AFRS-AIMS trial with 62 adults and children. The study’s findings showed dupilumab to reduce sinus opacification scores by 50% at week 52 compared with 10% with a placebo (P < .0001). Patients also reported nasal congestion improved 81% vs 11% by week 52, and nasal polyp scores fell 63% vs 4%.⁵

Another FDA approval in the biologic therapy space is amivantamab and hyaluronidase-lpuj (Rybrevant Faspro; Johnson & Johnson). The new drug was approved for a new, simplified monthly subcutaneous dosing schedule for patients with NSCLC and EGFR mutations.⁶

The approval will allow patients to transition from biweekly to once-monthly dosing as early as week 5 of treatment, streamlining care delivery even further and offering greater convenience for patients.

The findings were based on data from the phase 2 PALOME-2 study (NCT05498428) that included 77 patients with NSCLC. Although the DOR, OS, and PFS were not estimable by the cut-off, the investigator-assessed objective response rate was 82% (95% CI, 71%-90%). Furthermore, 87% of patients remained on the treatment 6.5 months after follow-up, indicating durable disease control.⁶

4. Glucagon-Like Peptide 1 Receptor Agonists and Incretin Therapies

Tirzepatide (Zepbound; Eli Lilly), a glucagon-like peptide-1 (GLP-1) receptor agonist, was approved for a label expansion allowing patients to use a single-use 4-dose KwikPen that can deliver an entire month of treatment in 1 device. The KwikPen used to treat chronic weight management expands options for patients to better suit their individual needs, preferences, and circumstances.⁷

Tirzepatide was the most prescribed weight management drug in 2025 and outperformed placebo and injectable semaglutide (Wegovy; Novo Nordisk) in phase 3 and 3b SURMOUNT-1 and -5 clinical trials (NCT04184622 and NCT05822830) in regard to weight loss.

However, since the popularity surge of GLP-1s, FDA-approved drugs are often in short supply, giving rise to the use of active pharmaceutical ingredients in compounded drugs. The practice of compounding, defined as combining, mixing, or altering drugs to create in a medication tailored to patients’ individual needs, is not FDA approved. ⁸

In early February, the FDA announced that it will restrict the use of active GLP-1 ingredients in compounded drugs. The agency’s statement also noted that there are exceptions to the restriction in the instance that compounding is medically necessary. Safety concerns contributed to the announcement, including improper storage during shipping and false information on the drug label.

5. New FDA Approval Pathway

The FDA issued draft guidance describing the “Plausible Mechanism Framework,” which introduces a new regulatory pathway aimed at streamlining approval of individualized genome editing and RNA-based therapies for ultrarare diseases.⁹

Although the guidance focuses on genome editing and RNA-based therapies, it is also applicable to other trial therapeutics. Overall, the guidance covers therapies targeting specific genetic, cellular, or molecular abnormalities to correct or modify the underlying cause of a disease.

Together, these FDA developments in February could continue to advance access to care, efficacious treatments, and public health priorities.

References

1. McCormick B. FDA grants accelerated approval to zongertinib for HER2-mutant NSCLC. AJMC^®. February 26, 2026. Accessed March 5, 2026. https://www.ajmc.com/view/fda-grants-accelerated-approval-to-zongertinib-for-her2-mutant-nsclc

2. Shaw M. FDA approval of CLL combo marks new era for leukemia care. AJMC. February 20, 2026. Accessed March 5, 2026. https://www.ajmc.com/view/fda-approval-of-cll-combo-marks-new-era-for-leukemia-care

3. McCormick B. FDA grants traditional approval to encorafenib combination for metastatic CRC with BRAF V600e mutation. AJMC. February 24, 2026. Accessed March 5, 2026. https://www.ajmc.com/view/fda-grants-traditional-approval-to-encorafenib-combination-for-metastatic-crc-with-braf-v600e-mutation

4. McNulty R. FDA approves first-in-class Optune Pax device for pancreatic cancer. AJMC. February 12, 2026. Accessed March 5, 2026. https://www.ajmc.com/view/fda-approves-first-in-class-optune-pax-device-for-pancreatic-cancer

5. McNulty R. FDA approves dupilumab for allergic fungal rhinosinusitis. AJMC. February 24, 2026. Accessed March 5, 2026. https://www.ajmc.com/view/fda-approves-dupilumab-for-allergic-fungal-rhinosinusitis

6. McCormick B. FDA approves once-Monthly SC amivantamab dosing in EGFR-mutated NSCLC. AJMC. February 17, 2026. Accessed March 5, 2026. https://www.ajmc.com/view/fda-approves-once-monthly-sc-amivantamab-dosing-in-egfr-mutated-nsclc

7. McCormick B. FDA approves monthly KwikPen option for tirzepatide in chronic weight management. AJMC. February 23, 2026. Accessed March 5, 2026. https://www.ajmc.com/view/fda-approves-monthly-kwikpen-option-for-tirzepatide-in-chronic-weight-management

8. McCormick B. FDA to restrict ingredients used in mass-marketed compounded GLP-1s, crack down on misleading ads. AJMC. February 9, 2026. Accessed March 5, 2026. https://www.ajmc.com/view/fda-to-restrict-ingredients-used-in-mass-marketed-compounded-glp-1s-crack-down-on-misleading-ads

9. McCormick B. FDA proposes new approval pathway for individualized ultra-rare disease therapies. AJMC. February 23, 2026. Accessed March 6, 2026. https://www.ajmc.com/view/fda-proposes-new-approval-pathway-for-individualized-ultra-rare-disease-therapies