Bayer Issues Voluntary Recall Nationwide of VITRAKVI® (larotrectinib) Oral Solution 20 mg/mL Due to Presence of Microbial Contamination
Bayer recalls one lot of cancer drug Vitrakvi due to contamination
PARIS & TOKYO--(BUSINESS WIRE)--Summit Pharmaceuticals International (Head Office: Chiyoda-ku, Tokyo; Chief Executive Officer: Katsuya Okuyama; hereinafter “SPI”) has signed an exclusive distributorship agreement in Japan with EVERZOM, SAS*. (hereinafter “EVERZOM”), a France-based company providing exosome manufacturing service.
With the rise of Merck’s Keytruda and Bayer’s Vitrakvi, which have won accelerated approvals over the last five years for genetically-targeted (rather than tissue-targeted) cancer therapies, the FDA on Monday released new draft guidance to help cancer drug developers try to make similar strides.
It’s been a month since cancer drug developers presented their latest research at the American Society of Clinical Oncology (ASCO) annual meeting, and the highlights are still reverberating across the industry.
WHIPPANY, N.J.--(BUSINESS WIRE)--Data from three subset analyses and one matching-adjusted indirect comparison (MAIC) model for Vitrakvi® (larotrectinib) showcase its consistent noteworthy clinical profile and add to its existing safety data for patients with solid tumors harboring an NTRK gene fusion (also known as TRK fusion cancer). These analyses add to the body of evidence for the compound, which has the largest dataset and longest follow-up of any TRK inhibitor. These results are being presented at the ESMO Congress 2021, to be held between September 16-21, 2021.
Berlin, May 25, 2021 – Bayer today announced the submission of a regulatory application to the Center of Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA), seeking approval of larotrectinib in China for the treatment of adult and pediatric patients with advanced solid tumors that display a neurotrophic tyrosine receptor kinase (NTRK) gene fusion. Larotrectinib is a highly selective TRK inhibitor exclusively designed to treat tumors that have an NTRK gene fusion. The product is already approved in several countries under the brand name Vitrakvi™, including the U.S., countries of the European Union (EU), and most recently Japan. Filings in other regions are underway or planned.
Foundation Medicine has nabbed a U.S. green light as the only companion diagnostic for Bayer’s Vitrakvi (larotrectinib).
The FDA has approved the FoundationOne CDx comprehensive genomic test as a companion diagnostic for larotrectinib (Vitrakvi) to identify patients with NTRK1/2/3 gene fusions across all solid tumors.
Bayer’s tumour agnostic therapy Vitrakvi has demonstrated sustained, long-term efficacy and safety in a number of tropomyosin receptor kinase (TRK) fusion-positive cancers, including lung and thyroid tumours.