Japan's Takeda Pharmaceutical said on Monday it will voluntarily withdraw its .. nnnRead more at: nhttps://health.economictimes.indiatimes.com/news/pharma/takeda-announces-voluntary-withdrawal-of-lung-cancer-therapy/104118437
Takeda Provides Update on EXKIVITY® (mobocertinib)
Targeted non-small cell lung drug Exkivity has failed in a phase 3 trial in newly diagnosed patients, and the study has stopped early, Takeda said Thursday in its quarterly earnings report.
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Foundation Medicine, Inc., a leader in molecular profiling for cancer, today announced that it has received approval from the U.S. Food and Drug Administration (FDA) for FoundationOne®Liquid CDx to be used as a companion diagnostic for EXKIVITY® (mobocertinib), which is currently FDA-approved 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. For full Indication, Important Safety Information and link to the Prescribing Information, please see ‘About Exkivity’ below. FoundationOne Liquid CDx is the only blood-based comprehensive genomic profiling (CGP) test that is FDA-approved to detect EGFR exon 20 insertion mutations to identify patients who may be appropriate for treatment with EXKIVITY.
Takeda’s EXKIVITY® (mobocertinib) Receives Approval from the NMPA of China, Becoming the First and Only Therapy Available for Patients with EGFR Exon20 Insertion+ NSCLC
The Medicines and Healthcare products Regulatory Agency (MHRA) has granted conditional marketing authorisation to Exkivity (mobocertinib) as a monotherapy for non-small-cell lung cancer (NSCLC) patients whose tumours have EGFR exon20 insertion mutations, after first-line chemotherapy.
While there were FDA setbacks for Calliditas and Verrica last month there were also a couple of early oncology approvals. One such win was for Tivdak, Seagen/Genmab’s treatment for recurrent or metastatic cervical cancer. However, expected sales of Tivdak could be hit by an unexpected black box warning regarding ocular toxicity. An early approval for Takeda’s Exkivity
OSAKA, Japan & CAMBRIDGE, Mass.--(BUSINESS WIRE)--Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) (“Takeda”) today announced that the U.S. Food and Drug Administration (FDA) has approved EXKIVITY (mobocertinib) for the treatment of 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. EXKIVITY, which was granted priority review and received Breakthrough Therapy Designation, Fast Track Designation and Orphan Drug Designation from the FDA, is the first and only approved oral therapy specifically designed to target EGFR Exon20 insertion mutations. This indication is approved under Accelerated Approval based on overall response rate (ORR) and DoR. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.
- Key Results from Phase 3 ALTA 1L Sub-Analyses Further Support ALUNBRIG’s Strong Intracranial Efficacy and Enhanced Quality of Life in First-Line ALK+ NSCLC