FDA grants priority review to mobocertinib for NSCLC subset
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The FDA granted priority review to mobocertinib for treatment of certain patients with non-small cell lung cancer, according to the agent’s manufacturer.
The designation applies to use of the agent for treatment of EGFR exon 20 insertion-positive metastatic NSCLC who received prior platinum-based chemotherapy.
Approximately 1% to 2% of patients with NSCLC have EGFR exon 20 insertion-positive metastatic disease. Prognosis for this subtype is worse than other subtypes because there are no FDA-approved therapies that target EGFR exon 20 insertions. Available EGFR tyrosine kinase inhibitors and chemotherapy confer limited benefit for this subgroup.
Mobocertinib (TAK-788, Takeda) is an oral TKI designed to target EGFR exon 20 insertion mutations.
An ongoing phase 1/phase 2 trial is evaluating the antitumor activity and safety of oral mobocertinib for patients with NSCLC. The trial includes 114 patients with EGFR exon 20 insertion-positive metastatic NSCLC who received prior platinum-based therapy. These patients received 160 mg mobocertinib once daily.
The FDA is expected to make a decision on this application by Oct. 26.
“Patients with EGFR exon 20 insertion-positive metastatic NSCLC face considerable challenges, as current treatment options provide limited benefit, resulting in poor survival outcomes,” Christopher Arendt, head of Takeda’s oncology therapeutic area unit, said in a company-issued press release. “We are excited to be one step closer to offering mobocertinib as an effective oral therapy for [patients with NSCLC] with EGFR exon 20 insertions who have received prior platinum-based chemotherapy and look forward to continuing conversations with regulatory agencies in the U.S. and around the globe.”
The FDA previously granted breakthrough therapy designation to mobocertinib for this indication.
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