The FDA on October 2, 2025, approved ZEPZELCA® in combination with Atezolizumab (TECENTRIQ®) or Atezolizumab and Hyaluronidase-tqjs (TECENTRIQ HYBREZA®) for the maintenance treatment of adult patients with Extensive-Stage Small Cell Lung Cancer (ES-SCLC) whose disease has not progressed after first-line induction therapy with TECENTRIQ® or TECENTRIQ HYBREZA®, Carboplatin, and Etoposide. ZEPZELCA® is a product of Jazz Pharmaceuticals, Inc. and TECENTRIQ® as well as TECENTRIQ HYBREZA® are products of Genentech Inc.
Category: FDA Approvals
INLURIYO® (Imlunestrant)
The FDA on September 25, 2025, approved INLURIYO® , an estrogen receptor antagonist, for adults with estrogen receptor (ER)-positive, human epidermal growth factor 2 (HER2)-negative, estrogen receptor-1 (ESR1)-mutated advanced or metastatic breast cancer with disease progression following at least one line of endocrine therapy. INLURIYO® is a product of Eli Lilly and Company.
KEYTRUDA QLEX® (Pembrolizumab and Berahyaluronidase alfa-pmph)
The FDA on September 19, 2025, approved KEYTRUDA QLEX® (Pembrolizumab and Berahyaluronidase alfa-pmph) (Keytruda Qlex, Merck) for subcutaneous injection for adult and pediatric (12 years and older) solid tumor indications approved for the intravenous formulation of pembrolizumab (Keytruda, Merck). See the prescribing information for the specific indications.
KOSELUGO® (Selumetinib)
The FDA on September 10, 2025, approved KOSELUGO® granules and capsules for pediatric patients 1 year of age and older with neurofibromatosis type 1 (NF1) who have symptomatic, inoperable Plexiform Neurofibromas (PN). FDA previously approved KOSELUGO® capsules for pediatric patients 2 years of age and older with NF1 who have symptomatic, inoperable PN. KOSELUGO® is a product of AstraZeneca Pharmaceuticals LP.
INLEXZO® (Gemcitabine intravesical system)
The FDA on September 9, 2025, approved INLEXZO® for adults with Bacillus Calmette-Guérin (BCG)-unresponsive Non-Muscle Invasive Bladder Cancer (NMIBC) with Carcinoma in Situ (CIS) with or without papillary tumors. Gemcitabine intravesical system is co-packaged with a urinary catheter and stylet used for insertion through the urinary catheter into the bladder. INLEXZO® is a product of Janssen Biotech, Inc.
HERNEXEOS® (Zongertinib)
The FDA on August 8, 2025, granted accelerated approval to HERNEXEOS®, a kinase inhibitor, 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-approved test, and who have received prior systemic therapy. HERNEXEOS® is a product of Boehringer Ingelheim Pharmaceuticals, Inc.
MODEYSO® (Dordaviprone)
The FDA on August 6, 2025, granted accelerated approval to MODEYSO®, a protease activator, for adult and pediatric patients 1 year of age and older with diffuse midline glioma harboring an H3 K27M mutation with progressive disease following prior therapy. MODEYSO® is a product of Jazz Pharmaceuticals, Inc.
ZEGFROVY® (Sunvozertinib)
The FDA on July 2, 2025, granted accelerated approval to ZEGFROVY® for adult patients with locally advanced or metastatic Non-Small Cell Lung Cancer (NSCLC) with Epidermal Growth Factor Receptor (EGFR) exon 20 insertion mutations, as detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy. ZEGFROVY® is a product of Dizal (Jiangsu) Pharmaceutical Co., Ltd.
LYNOZYFIC® (Linvoseltamab-gcpt)
The FDA on July 2, 2025, granted accelerated approval to LYNOZYFIC®, a bispecific B-Cell Maturation Antigen (BCMA)-directed CD3 T-cell engager, for adults with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, including a Proteasome Inhibitor (PI), an immunomodulatory agent (IMiD), and an anti-CD38 monoclonal antibody. LYNOZYFIC® is a product of Regeneron Pharmaceuticals, Inc.
DATROWAY® (Datopotamab deruxtecan-dlnk)
The FDA on June 23, 2025, granted accelerated approval to DATROWAY® for adults with locally advanced or metastatic Epidermal Growth Factor Receptor (EGFR)-mutated Non-Small Cell Lung Cancer (NSCLC) who have received prior EGFR-directed therapy and platinum-based chemotherapy. DATROWAY® is a product of Daiichi Sankyo, Inc.