The FDA on May 14, 2025, granted accelerated approval to EMRELIS®, a c-Met-directed antibody and microtubule inhibitor conjugate, for adults with locally advanced or metastatic, non-squamous Non-Small Cell Lung Cancer (NSCLC) with high c-Met protein overexpression [≥50% of tumor cells with strong (3+) staining], as determined by an FDA-approved test, who have received a prior systemic therapy. EMRELIS® is a product of AbbVie Inc.
Author: RR
AVMAPKI® (Avutometinib) and FAKZYNJA® (Defactinib) Co-pack
The FDA on May 8, 2025, granted accelerated approval to the combination of AVMAPKI® and FAKZYNJA® Co-pack, for adult patients with KRAS-mutated recurrent Low-Grade Serous Ovarian Cancer (LGSOC) who have received prior systemic therapy. AVMAPKI® and FAKZYNJA® are products of Verastem, Inc.
Penpulimab-kcqx
The FDA on April 23, 2025, approved Penpulimab-kcqx with Cisplatin or Carboplatin and Gemcitabine for the first-line treatment of adults with recurrent or metastatic non-keratinizing NasoPharyngeal Carcinoma (NPC). Penpulimab-kcqx is a product of Akeso Biopharma Co., Ltd.
OPDIVO® (Nivolumab) with YERVOY® (Ipilimumab)
The FDA on April 11, 2025, approved OPDIVO® with YERVOY® for the first-line treatment of adult patients with unresectable or metastatic HepatoCellular Carcinoma (HCC). OPDIVO® and YERVOY® are products of Bristol Myers Squibb Company.
OPDIVO® (Nivolumab) with YERVOY® (Ipilimumab)
The FDA on April 8, 2025, approved OPDIVO® with YERVOY® for adult and pediatric patients 12 years of age and older with unresectable or metastatic MicroSatellite Instability-High (MSI-H) or MisMatch Repair deficient (dMMR) ColoRectal Cancer (CRC). The FDA also converted the accelerated approval to regular approval for single agent OPDIVO® for adult and pediatric patients 12 years of age and older with MSI-H or dMMR metastatic CRC, that has progressed following Fuoropyrimidine, Oxaliplatin, and Irinotecan. OPDIVO® and YERVOY® are products of Bristol Myers Squibb Company.
IMFINZI® (Durvalumab)
The FDA on March 28, 2025, approved IMFINZI® with Gemcitabine and Cisplatin as neoadjuvant treatment, followed by single agent IMFINZI® as adjuvant treatment following radical cystectomy, for adults with Muscle Invasive Bladder Cancer (MIBC). IMFINZI® is a product of AstraZeneca.
PLUVICTO® (Lutetium Lu 177 vipivotide tetraxetan)
The FDA on March 28, 2025, expanded the indication for PLUVICTO® to include adults with Prostate-Specific Membrane Antigen (PSMA)-positive metastatic Castration-Resistant Prostate Cancer (mCRPC) who have been treated with Androgen Receptor Pathway Inhibitor (ARPI) therapy and are considered appropriate to delay Taxane-based chemotherapy. PLUVICTO® is a product of Novartis Pharmaceuticals Corporation.
CABOMETYX® (Cabozantinib)
The FDA on March 26, 2025, approved CABOMETYX® for adult and pediatric patients 12 years of age and older with previously treated, unresectable, locally advanced or metastatic, well-differentiated pancreatic NeuroEndocrine Tumors (pNET) and well-differentiated extra-pancreatic NeuroEndocrine Tumors (epNET). CABOMETYX® is a product of Exelixis, Inc.
KEYTRUDA® (Pembrolizumab)
The FDA on March 19, 2025, granted traditional approval to KEYTRUDA® with Trastuzumab, Fluoropyrimidine and Platinum-containing chemotherapy for the first-line treatment of adults with locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma, whose tumors express PD-L1 (CPS ≥1). KEYTRUDA® is a product of Merck.