The FDA on May 13, 2026, granted accelerated approval to BEQALZI®, a BCL-2 inhibitor, for adults with relapsed or refractory Mantle Cell Lymphoma (MCL) after at least two lines of systemic therapy, including a Bruton’s Tyrosine Kinase (BTK) inhibitor. BEQALZI® is a product of BeOne Medicines USA, Inc.
Author: RR
BIZENGRI® (Zenocutuzumab-zbco)
The FDA on May 8, 2026, approved BIZENGRI® for adults with advanced, unresectable or metastatic cholangiocarcinoma harboring a NeuReGulin 1 (NRG1) gene fusion with disease progression on or after prior systemic therapy. NRG1-fusion positive cholangiocarcinoma is an extremely rare, life-threatening malignancy. BIZENGRI® is a product of Partner Therapeutics, Inc.
VEPPANU® (Vepdegestrant)
The FDA on May 1, 2026, approved VEPPANU®, a heterobifunctional protein degrader, for adults with Estrogen Rreceptor (ER)-positive, Human Epidermal growth factor Receptor 2 (HER2)-negative, ESR1-mutated advanced or metastatic breast cancer, as detected by an FDA-authorized test, with disease progression following at least one line of endocrine therapy. VEPPANU® is a product of Arvinas Operations, Inc.
LIFYORLI® (Relacorilant)
The FDA on March 25, 2026, approved LIFYORLI®, a glucocorticoid receptor antagonist, in combination with nab-Paclitaxel for the treatment of adults with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who have received one to three prior systemic treatment regimens, at least one of which included Bevacizumab. LIFYORLI® is a product of Corcept Therapeutics Inc.
OPDIVO® (Nivolumab) with AVD
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.
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.