FDA Approves Novocure’s Optune Pax for the Treatment of Locally Advanced Pancreatic Cancer

On February 11, the FDA approved Optune Pax® for the treatment of adult patients with locally advanced pancreatic cancer concomitant with gemcitabine and nab-paclitaxel.

For more information, read the Novocure press release.

Posted on 2/13/2026

FDA Approves Pembrolizumab With Paclitaxel for Platinum-resistant Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Carcinoma

On February 10, the FDA approved pembrolizumab as well as pembrolizumab and berahyaluronidase alfa-pmph in combination with paclitaxel, with or without bevacizumab, for adult patients with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal carcinoma whose tumors express PD-L1 (CPS≥1) as determined by an FDA-authorized test, and who have received 1 or 2 prior systemic treatment regimens.

For more information, read the FDA announcement and the Merck press release.

Posted on 2/13/2026

Safety Labeling Update for Capecitabine and Fluorouracil on Risks Associated With Dihydropyrimidine Dehydrogenase Deficiency

The FDA is providing this communication to increase awareness of recent updates to the product labeling of capecitabine (Xeloda) and fluorouracil (5-FU) related to risks associated with dihydropyrimidine dehydrogenase (DPD) deficiency. All health care providers should be aware of the risks of DPD deficiency, inform patients prior to treatment about the potential for serious and life-threatening toxicities due to DPD deficiency, and test patients for genetic variants of DPYD prior to initiating treatment with capecitabine or 5-FU unless immediate treatment is necessary.

For more information, read the FDA announcement.

Posted on 2/6/2026

FDA Approves Genentech’s Lunsumio VELO™ for Subcutaneous Use in Relapsed or Refractory Follicular Lymphoma

On December 21, the FDA approved CD20xCD3 bispecific mosunetuzumab-axgb as a subcutaneous formulation for the treatment of adult patients with relapsed or refractory follicular lymphoma after 2 or more lines of systemic therapy, based on results from the Phase I/II GO29781 study.

For more information, read the Genentech press release.

Posted on 2/2/2026

FDA Approves Daratumumab and Hyaluronidase-fihj With Bortezomib, Lenalidomide, and Dexamethasone for Newly Diagnosed Multiple Myeloma

On January 27, the FDA approved daratumumab and hyaluronidase-fihj in combination with bortezomib, lenalidomide, and dexamethasone for adults with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant.

For more information, read the FDA announcement and the Johnson & Johnson press release.

Posted on 1/30/2026

Sun Pharma Announces the Availability of Cosibelimab-ipdl for Advanced Cutaneous Squamous Cell Carcinoma

On January 16, 2026, Sun Pharmaceutical Industries announced that UNLOXCYT™ (cosibelimab-ipdl) is now available in the US for health care professionals to prescribe for adults with metastatic cutaneous squamous cell carcinoma (mCSCC) or locally advanced CSCC who are not candidates for curative surgery or curative radiation.

For more information, read the Sun Pharmaceutical Industries press release.

Posted on 1/16/2026

FDA Approves Amivantamab and Hyaluronidase-lpuj for Subcutaneous Injection

On December 17, the FDA approved amivantamab and hyaluronidase-lpuj for subcutaneous injection for adult patients across all indications approved for the intravenous formulation of amivantamab.

For more information, read the FDA announcement and the Janssen Biotech press release.

Posted on 12/18/2025

FDA Grants Regular Approval to Rucaparib for Metastatic Castration-resistant Prostate Cancer

On December 17, the FDA approved rucaparib for adults with a deleterious BRCA mutation (germline and/or somatic)-associated metastatic castration-resistant prostate cancer previously treated with an androgen receptor-directed therapy. 

For more information, read the FDA announcement and visit the pharmaand website.

Posted on 12/18/2025

FDA Approves Fam-trastuzumab Deruxtecan-nxki With Pertuzumab for Unresectable or Metastatic HER2-positive Breast Cancer

On December 15, the FDA approved fam-trastuzumab deruxtecan-nxki in combination with pertuzumab for the first-line treatment of adults with unresectable or metastatic HER2-positive (IHC 3+ or ISH+) breast cancer as determined by an FDA-approved test.

For more information, read the FDA announcement and the AstraZeneca press release.

Posted on 12/18/2025

FDA Approves Niraparib and Abiraterone Acetate Plus Prednisone for BRCA2-mutated Metastatic Castration-sensitive Prostate Cancer

On December 12, the FDA approved niraparib and abiraterone acetate with prednisone for adults with deleterious or suspected deleterious BRCA2-mutated metastatic castration-sensitive prostate cancer, as determined by an FDA-approved test.

For more information, read the FDA announcement and visit the Janssen Biotech website.

Posted on 12/12/2025