FDA Approves New Dosage of Trastuzumab Biosimilar, First CLDN18.2-Targeted Therapy, and Delays Sotorasib Decision
核心洞察
The FDA has approved a 420-mg dose of trastuzumab-strf (Hercessi), a biosimilar to trastuzumab, for HER2-overexpressing metastatic breast and gastric cancers.
Zolbetuximab (Vyloy) received FDA approval as the first CLDN18.2-targeted therapy for locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction adenocarcinoma (搜索).
The FDA delayed its decision on the sNDA for sotorasib (Lumakras) plus panitumumab (Vectibix) in chemorefractory metastatic colorectal cancer (搜索) with a KRAS G12C (搜索) mutation until January 17, 2025.
The FDA has recently approved several new treatments and updates for various cancers, including approvals for a trastuzumab biosimilar, a novel targeted therapy for gastric cancer (搜索), and a delay in the decision for a sotorasib combination therapy. These approvals and updates signify advancements in cancer treatment options and highlight the ongoing efforts to address unmet medical needs.
Trastuzumab Biosimilar Approved for HER2-Overexpressing Cancers
The FDA has approved the 420-mg dose of trastuzumab-strf (Hercessi), a biosimilar to trastuzumab (Herceptin), for the treatment of HER2-overexpressing cancers (搜索), including metastatic breast and gastric and gastroesophageal junction cancers (搜索). The initial approval of the 150-mg dose in April 2024 was based on a phase 3 trial (NCT03084237) demonstrating comparable safety and pharmacokinetic similarity to the reference product, trastuzumab. According to Jason Zhu, MD, executive director and chief executive officer of Henlius, this approval represents an important step in meeting the needs of patients with innovative and affordable therapeutics.
First-Line Zolbetuximab Approved for CLDN18.2-Positive Gastric Cancer
Zolbetuximab (Vyloy) has received FDA approval for the first-line treatment of locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma that is claudin (CLDN) 18.2-positive. This marks the first CLDN 18.2 (搜索)-targeted therapy approved for this patient population. The approval is based on data from the phase 3 SPOTLIGHT (NCT03504397) and GLOW (NCT03653507) trials. In the SPOTLIGHT trial, zolbetuximab plus mFOLFOX6 was compared with placebo plus mFOLFOX6, while in the GLOW trial, zolbetuximab plus CAPOX was compared with placebo plus CAPOX. The FDA had previously issued a complete response letter in January 2024 due to third-party manufacturing deficiencies, but no concerns were raised regarding the clinical data, and no additional studies were requested.
Sotorasib Decision Delayed for Chemorefractory Metastatic Colorectal Cancer
The FDA has delayed its decision regarding the supplemental new drug application (sNDA) for sotorasib (Lumakras) plus panitumumab (Vectibix) in the treatment of chemorefractory metastatic colorectal cancer (搜索) (CRC) with a KRAS G12C mutation. The new target action date is set for January 17, 2025. This delay allows the FDA to review supplemental information recently submitted by Amgen, the sponsor of the sNDA. The application is based on data from the phase 3 CodeBreaK 300 study (NCT05198934). Data presented at the 2024 ASCO meeting showed a trend toward overall survival improvement for patients receiving the 960-mg dose of sotorasib with panitumumab, although statistical significance was not reached.