Takeda Therapy Quickly Gets FDA Green Light for Lung Cancers with Rare Genetic Signature

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Takeda Pharmaceutical’s anticancer drug portfolio added another FDA-approved product, a targeted therapy that treats tumors with a rare genetic signature.

The FDA has approved Takeda’s drug, mobocertinib, for adults whose non-small cell lung cancer has spread, locally or to other parts of the body, after treatment with chemotherapy. The cancer should be characterized by an insertion mutation at exon 20 of the epidermal growth factor receptor (EGFR), a protein involved in cell signaling. EGFR mutations contribute to the rapid cell growth of tumors.

Non-small cell lung cancer is the most common form of lung cancer, accounting for about 85% of all new cases diagnosed each year. However, EGFR exon 20 insertion mutations are rare, accounting for approximately 1% to 2% of cases. Currently available anticancer drugs that target EGFR do not work against EGFR exon 20 insertion mutations.

The first drug that targets this mutation, Rybrevant from Johnson & Johnson, received the regulatory green light in May. But this bispecific antibody is administered by infusion. The drug Takeda is a small molecule that comes in a capsule form, making it the first oral treatment for this particular genetic mutation. Takeda will market its new cancer drug under the name “Exkivity”.

The FDA’s approval of Exkivity was based on the results of an open-label phase 1/2 study that evaluated the drug Takeda in 114 patients whose cancer carried the EGFR exon 20 insertion mutation. . The patients took the drug once a day. The main objective of the clinical trial was to measure the overall response rate and the duration of response.

The FDA said the overall response rate was 28%; the median duration of this response was 17.5 months. The results also showed that the overall survival of the patients was a median of 24 months. Takeda presented the updated study results at the American Society of Clinical Oncology annual conference in May.

The most common side effects reported in the study included diarrhea, rash, nausea, inflammation and pain in the mouth, and vomiting. The drug label has a black box warning that alerts doctors and patients that the drug can cause a heart rhythm problem that could become fatal. Patients should be monitored for heart rhythm problems while taking the medicine.

EGFR exon 20 insertion mutation should be detected by companion diagnosis. Along with Exkivity’s regulatory approval, the FDA also approved a Thermo Fisher Scientific test that identifies the mutation.

Approval for the drug Takeda came earlier than expected. The FDA’s target date for a decision was October 26. The decision was expedited approval based on less evidence than is typically required for a drug review. Such approvals force pharmaceutical companies to conduct post-market studies to confirm efficacy, continuing to show that a drug’s benefits outweigh the safety risks.

Photo: Scott Eisen / Bloomberg, via Getty Images

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