UPDATED: BI plays hot potato with Hanmi, returns cancer drug
This article was updated after publication to include comments from the company.
- Boehringer Ingelheim announced Friday morning it is handing back rights to the lung cancer drug olmutinib, a third-generation EGRF inhibitor, to Hanmi Pharmaceuticals.
- The decision comes after reports surfaced in local Korean newspapers that two patients had died while taking the drug. The patients had first developed severe skin reactions — a side effect seen in earlier clinical trials, according to The Korean Herald. The drug is already approved in South Korea.
- Boehringer said in its statement to the press that "the decision was based on a re-evaluation of all available clinical data on olmutinib and recent treatment advances made in the treatment of EGFR mutation-positive lung cancer."
The German drug company says it will not initiate any further clinical trials of the drug and will work to transition the right of olmutinib back to Hanmi.
Boehringer picked up the rights to the lung cancer treatment back in July 2015 when it paid $50 million upfront and promised another $680 million in milestone payments, as well as tiered double-digit royalties.
The drug was in Phase 2 at the time of the deal and had been expected to gain U.S. approval by 2017. The U.S. Food and Drug Administration granted a breakthrough therapy designation to the drug in December 2015.
Updated: Boehringer responded to requests for comment after the time of initial publication. The company said in an email that the South Korean Authority issued a drug safety letter on Friday. "The letter refers to two cases of toxic epidermal necrolysis, one of them fatal, and one case of Stevens-Johnson-Syndrome (non-fatal). Patient safety is our highest priority. We previously informed regulatory authorities, including the FDA, about relevant safety data related to olmutinib, including side effects such as severe skin reactions. For studies for which Boehringer Ingelheim is responsible all investigators received timely communications regarding these findings and were instructed to inform their patients accordingly," wrote a Boehringer spokesman in an email.
Clovis oncology had also been developing a third-generation EGFR inhibitor for EGFR T790M–mutated non–small cell lung cancer (NSCLC) dubbed rociletinib, but abandoned the drug in May 2016 after receiving a complete response letter from the FDA. The regulatory agency's rejection followed a negative vote from an advisory committee meeting, as well as troublesome data in mid-stage trials.
- Boehringer Ingelheim Statement
- The Korean Herald Two patients died during Hanmi Pharma's lung cancer drug candidate's clinical trial
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