U.S. FDA Grants Priority Review for New Lung Cancer Drug
Osaka-based Takeda Pharmaceutical Company Limited announced that that the U.S. Food and Drug Administration (FDA) has granted priority review for the company’s New Drug Application (NDA) for mobocertinib (TAK-788) for the treatment of adult patients with epidermal growth factor receptor (EGFR) Exon20 insertion mutation-positive (insertion+) metastatic non-small cell lung cancer (mNSCLC), as detected by an FDA-approved test, who have received prior platinum-based chemotherapy.
Mobocertinib is the first oral therapy specifically designed to selectively target EGFR Exon20 insertion mutations.
“Patients with EGFR Exon20 insertion+ mNSCLC face considerable challenges, as current treatment options provide limited benefit, resulting in poor survival outcomes,” said Christopher Arendt, Head of Oncology Therapeutic Area Unit Takeda, in a press release issued on April 27, 2021.
“We are excited to be one step closer to offering mobocertinib as an effective oral therapy for NSCLC patients with EGFR Exon20 insertions that have received prior platinum-based chemotherapy and look forward to continuing conversations with regulatory agencies in the U.S. and around the globe.”
The NDA for mobocertinib is primarily based on results from the Phase 1/2 trial, which evaluates the safety and efficacy of oral mobocertinib in patients with mNSCLC.
Takeda Pharmaceutical Company Limited (TSE: 4502/NYSE: TAK) is a global, values-based, R & R&D-driven biopharmaceutical leader headquartered in Japan, committed to discovering and delivering life-transforming treatments, guided by our commitment to patients, our people, and the planet.