Oncology Frontiers: Recapping a Milestone February for FDA Approvals

February 2026 proved to be a pivotal month for the oncology landscape, as the FDA green-lit several therapies targeting some of the most challenging diagnoses in modern medicine. From the introduction of noninvasive technologies for pancreatic cancer to the streamlining of lung cancer treatments through subcutaneous delivery, these decisions emphasize a clear regulatory trend: prioritizing both clinical efficacy and patient quality of life.

This month's actions reflect a dual focus on high-tech innovation and the refinement of existing standards. By transitioning accelerated approvals to traditional ones and introducing the first all-oral regimens for specific leukemias, the FDA is helping to reduce the treatment burden for patients while solidifying new benchmarks for care.

Traditional and Accelerated Approvals

Tumor Treating Fields Therapy Garners FDA Approval in Locally Advanced Pancreatic Cancer

The FDA has approved a new tumor treating fields (TTFields) therapy, Optune Pax, for the treatment of adult patients with locally advanced pancreatic cancer concomitant with gemcitabine and nab-paclitaxel.

Why It Matters: Optune Pax offers a precise, potent, and noninvasive approach to treating pancreatic cancer, a deadly disease with poor prognosis.

In a First, FDA Approves Monthly Subcutaneous Amivantamab for EGFR+ NSCLC

The FDA has approved amivantamab-vmjw and hyaluronidase-lpuj (Rybrevant Faspro) for a subcutaneous (SC) dosing regimen that allows for once-monthly administration following an initial induction phase. This approval specifically applies to the treatment of adult patients with locally advanced or metastatic non–small cell lung cancer (NSCLC) harboring EGFR exon 19 deletions or exon 21 L858R substitution mutations, used in combination with lazertinib (Lazcluze) as a first-line therapy.

Why It Matters: This regulatory milestone establishes the combination as the first and only EGFR-targeted therapy capable of monthly maintenance dosing, significantly reducing the treatment burden for this patient population.

FDA Approves Acalabrutinib Plus Venetoclax for Previously Untreated CLL/SLL

The FDA has approved acalabrutinib (Calquence) in combination with venetoclax (Venclexta) for first-line treatment of adult patients with chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL).

Why It Matters: This marks the first US approval of an all-oral, fixed-duration regimen involving a second-generation Bruton tyrosine kinase (BTK) inhibitor in this patient population.

FDA Grants Encorafenib Combo Traditional Approval in BRAF V600E+ mCRC

The FDA granted full approval encorafenib (Braftovi) in combination with cetuximab (Erbitux) and fluorouracil-based chemotherapy for the treatment of adult patients with metastatic colorectal cancer (mCRC) harboring a BRAF V600E mutation.

Why It Matters: This transition from accelerated approval to traditional approval signifies a definitive confirmation of the clinical benefit of the combination in a patient population historically associated with poor prognosis and limited treatment options.

FDA Grants Accelerated Approval to Zongertinib for HER2-Mutant NSCLC

The FDA has granted accelerated approval to zongertinib (Hernexeos) for the treatment of adults with unresectable or metastatic nonsquamous non–small cell lung cancer (NSCLC).This indication specifically targets patients whose tumors harbor HER2 tyrosine kinase domain (TKD) activating mutations, as detected by an FDA-authorized test.

Why It Matters: This approval expands the indication of zongertinib. In August 2025, the FDA granted accelerated approval to the agent in patients who had received prior systemic therapy.

NDA and BLA Acceptances

FDA Accepts NDA of Zanzalintinib Combo for Pretreated Metastatic CRC

The FDA accepted for review a new drug application (NDA) for zanzalintinib (formerly XL092) combined with atezolizumab (Tecentriq) for treatment of adult patients with metastatic colorectal cancer previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy and, if RAS wild-type, an anti-EGFR therapy.A Prescription Drug User Fee Act (PDUFA) target action date has been set for December 3, 2026.

Why It Matters: The acceptance of the NDA marks a significant regulatory milestone for a patient population that has traditionally seen limited benefit from chemotherapy-based regimens.

FDA Grants Priority Review to Dato-DXd First-Line Metastatic TNBC

The FDA accepted and granted priority review to the supplemental biologics license application (sBLA) for datopotamab deruxtecan (Dato-DXd; Datroway) for the treatment of adult patients with unresectable or metastatic triple-negative breast cancer (TNBC). Under the Prescription Drug User Fee Act, the target action date is expected in Q2 of 2026.

Why It Matters: The designation specifically applies to patients who are not candidates for PD-1 or PD-L1 inhibitor therapy.

FDA Review Restarts for Rivoceranib/Camrelizumab in Advanced HCC

An NDA and BLA have been resubmitted and accepted by the FDA for rivoceranib (formerly apatinib) and camrelizumab (SHR-1210), respectively, for first-line treatment of unresectable or metastatic hepatocellular carcinoma (HCC), marking the agency’s third formal review of the combination. The FDA has assigned a PDUFA target action date of July 23, 2026.

Why It Matters: The resubmission follows a series of regulatory setbacks and aims to address previous manufacturing-related issues that resulted in complete response letters in May 2024 and March 2025.

FDA Accepts sNDA for Photodynamic Therapy in Superficial Basal Cell Carcinoma

The FDA has accepted the sNDA for aminolevulinic acid hydrochloride 10% topical gel (Ameluz) as part of photodynamic therapy for patients with superficial basal cell carcinoma. The FDA has assigned a PDUFA goal date of September 28, 2026.

Why It Matters: The application seeks to expand the current indication for the drug, when used in combination with the Biofrontera RhodoLED red-light lamp series, beyond its existing approval for actinic keratosis.

FDA Accepts NDA for Iberdomide-Based Regimen in Multiple Myeloma

The FDA accepted an NDA for iberdomide (CC-220) in combination with daratumumab (Darzalex) and dexamethasone for patients with relapsed or refractory multiple myeloma, assigning a PDUFA date of August 17, 2026.

Why It Matters: The FDA also granted breakthrough therapy designation and priority review for the regimen. The application is notable for its reliance on MRD negativity as a dual primary end point alongside progression-free survival, underscoring the growing regulatory interest in MRD as a surrogate end point supporting drug approval in multiple myeloma.

FDA Accepts New Drug Application for BTK Inhibitor Tirabrutinib

The FDA has accepted the new drug application (NDA) for tirabrutinib (ONO-4059), a highly selective, irreversible, second-generation BTK inhibitor developed for the treatment of patients with relapsed or refractory primary central nervous system lymphoma. The application is being reviewed under the FDA’s accelerated approval pathway, with a designated PDUFA action date of December 18, 2026.

Why It Matters: If approved, tirabrutinib would become the first BTK inhibitor commercially available in the US for this specific patient population, addressing a critical unmet medical need for a rare and aggressive form of non-Hodgkin lymphoma.

FDA Accepts New Drug Application for Giredestrant in Advanced Breast Cancer

The FDA has accepted an NDA for giredestrant, an investigational oral selective estrogen receptor degrader (SERD), for the treatment of adult patients with estrogen receptor (ER)-positive, HER2-negative, ESR1-mutated locally advanced or metastatic breast cancer. The application seeks approval for giredestrant in combination with everolimus for patients whose disease has progressed following treatment with a CDK4/6 inhibitor and endocrine therapy. The FDA is expected to reach a regulatory decision by December 18, 2026.

Why It Matters: If approved, this would represent the first and only all-oral SERD-containing combination therapy available for patients in the post-CDK4/6 inhibitor setting.

Label Updates

FDA Updates Safety Labels for Capecitabine, 5-FU

The FDA has updated the safety labeling for the chemotherapeutic agents capecitabine (Xeloda) and fluorouracil (5-FU) to include new warnings regarding the risk of severe, life-threatening, or fatal toxicities in patients with dihydropyrimidine dehydrogenase (DPD) deficiency. The revised labeling, which affects both "Warnings and Precautions" and "Patient Counseling Information" sections, emphasizes the importance of identifying patients at increased risk for toxicity due to impaired drug metabolism.1

FDA Approves Label Update for Axi-Cel for R/R Primary CNS Lymphoma

The FDA has approved a label update for axicabtagene ciloleucel (axi-cel; Yescarta), a CD19-directed autologous T-cell immunotherapy. This update removes previous Limitations of Use for patients with relapsed or refractory (R/R) primary central nervous system lymphoma (PCNSL).1

Axi-cel is the first and only chimeric antigen receptor (CAR) T-cell therapy approved for R/R large B-cell lymphoma (LBCL) to have this limitation removed, expanding access to a patient population with high unmet clinical needs.