EMA Validates Bristol Myers Squibb's Repotrectinib Application for ROS1-Positive and NTRK-Positive Tumors
核心洞察
The European Medicines Agency (EMA) has validated Bristol Myers Squibb (搜索)'s marketing authorization application (MAA) for repotrectinib.
The MAA seeks approval for treating ROS1 (搜索) TKI-naïve and pretreated NSCLC (搜索) patients, as well as NTRK (搜索)-positive solid tumor patients.
The application is based on positive results from the TRIDENT-1 and CARE studies, demonstrating robust responses and durability.
Bristol Myers Squibb (搜索) (BMY) has announced the European Medicines Agency (EMA) validation of its marketing authorization application (MAA) for repotrectinib, a next-generation tyrosine kinase inhibitor (TKI). This application seeks approval for repotrectinib's use in treating adult patients with ROS1 (搜索)-positive locally advanced or metastatic non-small cell lung cancer (搜索) (NSCLC (搜索)), both TKI-naïve and pretreated, as well as adult and pediatric patients (12 years and older) with NTRK (搜索)-positive locally advanced or metastatic solid tumors, also TKI-naïve and pretreated.
The MAA is supported by data from the registrational phase I/II TRIDENT-1 trial (adult patients with ROS1 (搜索)-positive NSCLC (搜索) or NTRK (搜索)-positive solid tumors) and the CARE study (pediatric patients with NTRK-positive solid tumors). These studies demonstrated robust and durable responses in the respective patient populations.
In November 2023, the U.S. Food and Drug Administration (FDA) approved repotrectinib as an oral therapy for NSCLC (搜索) under the brand name Augtyro. This drug became part of Bristol Myers Squibb (搜索)'s portfolio following the acquisition of Turning Point Therapeutics in August 2022. The approval of repotrectinib will enhance Bristol Myers Squibb's NSCLC portfolio and strengthen its position in precision medicine.
Bristol Myers Squibb (搜索) is currently transitioning its focus from mature products facing generic competition to new drugs. The potential approval of repotrectinib and other new drugs is expected to diversify the company's product base and mitigate the impact of declining revenues from drugs like Revlimid and Eliquis as they encounter generic competition.
Bristol Myers Squibb (搜索) is also in the process of acquiring Mirati Therapeutics (搜索), an oncology-focused company, for $5.8 billion. This acquisition will add Mirati’s lung cancer drug, Krazati (adagrasib), to Bristol Myers Squibb’s oncology portfolio. Krazati received FDA approval in December 2022 for treating adult patients with KRAS-mutated locally advanced or metastatic NSCLC (搜索) who have previously undergone at least one systemic therapy.
The NSCLC (搜索) market is highly competitive, with key players such as Merck (搜索)'s Keytruda. NSCLC accounts for approximately 85% of all lung cancer diagnoses and remains the leading cause of cancer-related deaths in the United States. The two primary types of lung cancer are non-small cell lung cancer (搜索) and small cell lung cancer.
In October 2023, Merck (搜索) received FDA approval for Keytruda for the treatment of patients with resectable NSCLC (搜索) in combination with platinum-containing chemotherapy as neoadjuvant treatment and then continued as a single agent as adjuvant treatment after surgery. This approval expanded Keytruda's indications to six in NSCLC, covering both metastatic and earlier stages of the disease.