The FDA on March 20, 2026, approved OPDIVO® (Nivolumab) with Doxorubicin, Vinblastine, and Dacarbazine (AVD) for adult and pediatric patients 12 years and older with previously untreated, Stage III or IV classical Hodgkin lymphoma (cHL). OPDIVO® is a product of Bristol Myers Squibb Company.
Category: FDA Approvals
TECVAYLI® (Teclistamab) with Daratumumab hyaluronidase-fihj
The FDA on March 5, 2026, approved TECVAYLI® in combination with Daratumumab hyaluronidase-fihj for adult patients with relapsed or refractory multiple myeloma who have received at least one prior line of therapy including a Proteasome Inhibitor and an Immunomodulatory agent. TECVAYLI® is a product of Janssen Biotech, Inc.
HERNEXEOS® (Zongertinib)
The FDA on February 26, 2026, granted accelerated approval to HERNEXEOS®, a kinase inhibitor, for an expanded indication for adults with unresectable or metastatic non-squamous Non-Small Cell Lung Cancer (NSCLC) whose tumors have HER2 (ERBB2) Tyrosine Kinase Domain (TKD) activating mutations, as detected by an FDA-authorized test. HERNEXEOS® is a product of Boehringer Ingelheim Pharmaceuticals, Inc.
BRAFTOVI® (Encorafenib) with Cetuximab and Fluorouracil-based Chemotherapy
The FDA on February 24, 2026, granted traditional approval to BRAFTOVI® in combination with Cetuximab and Fluorouracil-based chemotherapy for the treatment of adult patients with metastatic Colorectal Cancer (CRC) with a BRAF V600E mutation, as detected by an FDA-authorized test. BRAFTOVI® received accelerated approval in combination with Cetuximab and mFOLFOX6 for metastatic colorectal cancer with BRAF V600E mutation in 2024. BRAFTOVI® is a product of Array BioPharma Inc., a subsidiary of Pfizer Inc.
CALQUENCE® (Acalabrutinib) with VENCLEXTA® (Venetoclax)
The FDA on February 19, 2026, approved CALQUENCE® tablets and capsules in combination with VENCLEXTA® for adults with Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL). CALQUENCE® is a product of AstraZeneca and VENCLEXTA® is a product of AbbVie Inc. and Genentech Inc.
KEYTRUDA® (Pembrolizumab) and KEYTRUDA QLEX® (Pembrolizumab and berahyaluronidase alfa-pmph)
The FDA on February 10, 2026, approved KEYTRUDA®, as well as KEYTRUDA QLEX® 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 one or two prior systemic treatment regimens. KEYTRUDA® and KEYTRUDA QLEX® are products of Merck & Co.
DARZALEX FASPRO® (Daratumumab and hyaluronidase-fihj)
The FDA on January 27, 2026, approved DARZALEX FASPRO® in combination with Bortezomib, Lenalidomide, and Dexamethasone (VRd) for adults with newly diagnosed multiple myeloma who are ineligible for Autologous Stem Cell Transplant (ASCT). DARZALEX FASPRO® is a product of Janssen Biotech, Inc.
DARZALEX FASPRO® (Daratumumab and Hyaluronidase-fihj)
The FDA on January 27, 2026, approved DARZALEX FASPRO® in combination with Bortezomib, Lenalidomide, and Dexamethasone (VRd) for adults with newly diagnosed multiple myeloma who are ineligible for Autologous Stem Cell Transplant (ASCT). DARZALEX FASPRO® is a product of Janssen Biotech, Inc.
RYBREVANT FASPRO® (Amivantamab and Hyaluronidase-lpuj)
The FDA on December 17, 2025, approved RYBREVANT FASPRO® for subcutaneous injection for adult patients across all indications approved for the intravenous formulation of RYBREVANT®. See the prescribing information for the specific indications. RYBREVANT FASPRO® is a product of Janssen Biotech, Inc.
AKEEGA® (Niraparib and Abiraterone acetate)
The FDA on December 12, 2025, approved AKEEGA® with prednisone for adults with deleterious or suspected deleterious BRCA2-mutated (BRCA2m) metastatic Castration-Sensitive Prostate Cancer (mCSPC), as determined by an FDA-approved test. AKEEGA® is a product of Janssen Biotech, Inc.