The FDA on June 11, 2025, approved IBTROZI®, a kinase inhibitor, for adults with locally advanced or metastatic ROS1-positive Non-Small Cell Lung Cancer (NSCLC). IBTROZI® is a product of Nuvation Bio Inc.
Category: FDA Approvals
NUBEQA® (Darolutamide)
The FDA on June 3, 2025, approved NUBEQA® for metastatic Castration-Sensitive Prostate Cancer (mCSPC). The FDA previously approved NUBEQA® in combination with Docetaxel for mCSPC. NUBEQA® is a product of Bayer Healthcare Pharmaceuticals Inc.
ZYNYZ® (Retifanlimab-dlwr)
The FDA on May 15, 2025, approved ZYNYZ® with Carboplatin and Paclitaxel for the first-line treatment of adults with inoperable locally recurrent or metastatic Squamous Cell Carcinoma of the Anal Canal (SCAC). The FDA also approved ZYNYZ®, as a single agent, for adults with locally recurrent or metastatic SCAC with disease progression on or intolerance to Platinum-based chemotherapy. ZYNYZ® is a product of Incyte Corporation.
EMRELIS® (Telisotuzumab vedotin-tllv)
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.
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.