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FDA grants breakthrough therapy designation to BI 1482694 for NSCLC
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The FDA granted breakthrough therapy designation to BI 1482694 for the treatment of patients with EGFR-mutated non–small cell lung cancer who have T790M mutations, according to a press release from the drug’s manufacturer.
BI 1482694 (Boehringer Ingelheim) is a third-generation EGFR mutant-selective tyrosine kinase inhibitor intended to target tumors with T790M mutations.
“We feel this designation reflects the potential of the compound to be an important part of the treatment of non–small cell lung cancer in patients with T790M mutation,” Tarek Sahmoud, MD, PhD, vice president of oncology clinical development and medical affairs at Boehringer Ingelheim, said in the press release.
The FDA based its decision in part on results from the phase 1/phase 2 HM-EMSI-101 clinical trial, which evaluated the agent for the treatment of patients with T790M-mutated NSCLC whose tumors stopped responding to available EGFR-directed therapies.
Results showed 62% of patients achieved objective responses, and researchers reported a 91% disease control rate as calculated by independent assessment. Median duration of response had not been reached at the time of data cut-off.
The most common adverse events associated with treatment included diarrhea (all grade, 55%; grade 3, 0%), nausea (all grade, 37%; grade 3, 0%), rash (all grade, 38%; grade 3, 5%) and skin itching (all grade, 36%; grade 3, 1%).