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Takeda’s lung cancer drug granted FDA priority review

Published on 29/04/21 at 12:14pm
Takeda building

The FDA has granted priority review for Takeda’s New Drug Application (NDA) for its mobocertinib drug for the treatment of patients with metastatic non-small cell lung cancer (mNSCLC).

The therapy is specifically for adult patients with epidermal growth factor receptor (EGFR) Exon20 insertion mutations, who have received prior platinum-based chemotherapy. Mobocertinib is the first oral therapy specifically designed to selectively target these mutations.

The NDA for Takeda’s treatment, which was submitted under the FDA’s accelerated approval program, is primarily based on results from a Phase I/II trial.

Mobocertinib demonstrated clinically meaningful responses in the trial, with a confirmed objective response rate of 35% as assessed by an investigator, and 28% as assessed by an independent review committee (IRC).

Responses shown with mobocertinib were also durable, with a median duration of response of 17.5 months as assessed by an IRC.

The analysis came from 114 patients who had received prior platinum-based therapy and were treated with 160mg of mobocertinib once daily.

Mobocertinib is an investigational, first-in-class, oral tyrosine kinase inhibitor (TKI) specifically designed to selectively target EGFR Exon20 insertion mutations. In 2019, the FDA granted mobocertinib Orphan Drug Designation for the treatment of lung cancer with HER2 mutations or EGFR mutations including Exon20 insertion mutations.

Non-small cell lung cancer (NSCLC) is the most common form of lung cancer, accounting for approximately 85% of the estimated 1.8 million new cases of lung cancer diagnosed each year worldwide, according to WHO.

Christopher Arendt, Head of the Oncology Therapeutic Area Unit at Takeda, said: “Patients with EGFR Exon20 insertion+ mNSCLC face considerable challenges, as current treatment options provide limited benefit, resulting in poor survival outcomes. 

“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 US and around the globe.”

Jack Goddard

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