
FDA Approves Exkivity, a Novel Oral Therapy for Lung Cancer
Takeda Oncology’s Exkivity treats non-small lung cancer in patients with EGFR exon 20 insertion mutations. This is the second approval for this mutation and the first oral therapy.
The FDA has
Exkivity, which was granted priority review and received breakthrough therapy designation, fast track designation, and orphan drug designation from the FDA, is the first approved oral therapy to target EGFR exon 20 insertion mutations.
This indication is approved under accelerated approval based on overall response rate and duration of response. The FDA approval is based on results from the platinum-pretreated population in the phase 1/2 trial of Exkivity in patients who had received prior platinum-based therapy. Results were presented at the
The most common adverse reactions were diarrhea, rash, nausea, vomiting, decreased appetite, fatigue, dry skin, and musculoskeletal pain.
“EGFR exon20 insertion NSCLC is an underserved cancer that we have been unable to target effectively with traditional EGFR tyrosine kinase inhibitors,” Pasi A. Jänne, M.D., Ph.D., director of the Lowe Center for Thoracic Oncology at Dana Farber Cancer Institute, said in a statement. “The approval of EXKIVITY (mobocertinib) marks another important step forward that provides physicians and their patients with a new targeted oral therapy specifically designed for this patient population that has shown clinically meaningful and sustained responses.”
At the same time, the FDA also
Non-small cell lung cancer is the most common form of lung cancer,
Another therapy for exon 20 insertion mutations was approved earlier this year for this indication. In May 2021, the FDA
At the same time, the FDA
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