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Blueprint gets FDA priority review for competitor to newly approved Lilly cancer drug

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Eli Lilly may have won the first-ever Food and Drug Administration approval for a drug that targets a genomic abnormality expressed in lung cancer, but another company has a potentially close competitor in the works.

Cambridge, Massachusetts-based Blueprint Medicines said Friday that the Food and Drug Administration and European Medicines Agency had accepted its applications to the respective agencies seeking approval of its RET inhibitor, pralsetinib, in non-small cell lung cancer. The FDA has given the drug a priority review to the application and plans to rule on it by Nov. 23.

Shares of Blueprint were down more than 4% on the Nasdaq following the news.

The company is presenting data on the drug in a poster at the American Society of Clinical Oncology’s annual meeting. The news follows the FDA’s accelerated approval of Indianapolis-based Lilly’s Retevmo (selpercatinib) in RET fusion-positive NSCLC and thyroid cancer and RET mutation-positive medullary thyroid cancer. Blueprint said it plans to file for FDA approval of pralsetinib in RET mutant- and fusion-positive thyroid cancers next month.

One factor that could help determine the competitive landscape between pralsetinib and Lilly’s drug is the widespread perception that there is little to differentiate the two. While RET fusions are rare, their presence and function as genetic drivers of cancer enable a high probability that targeting them will produce a response.

“I think the clinical activity is similar between the two drugs, and I think both are examples of when you develop highly selective drugs against a target, you can have good clinical efficacy,” said Dr. Pasi Janne, a medical oncologist specializing in lung cancer at the Dana-Farber Cancer Institute, in a phone interview.

Data being presented at the meeting for NSCLC show a 61% overall response rate among patients previously treated with platinum-based chemotherapy and a 73% ORR in previously untreated patients. Among the previously untreated patients, the complete response rate was 12%. Median duration of response was not reached, but the duration of response rate at six months was 86%.

“Prior to having these drugs, we in the oncology community were trying to repurpose existing drugs like cabozantinib, drugs that inhibit RET but were developed to inhibit [other targets],” Janne said, referring to Exelixis’ Cabometyx, which primarily inhibits c-MET and VEGFR2.

The bigger question, Janne said, is determining ways the more specific RET inhibitors might stop working in patients. “How does resistance happen? Can you develop combinatory strategies to build on the nice single-agent activity?”

Blueprint is sponsoring a Phase III open-label study in NSCLC that compares pralsetinib against a range of chemotherapy drugs and Merck’s Keytruda (pembrolizumab). Lilly is running a Phase III study with a similar design.

Photo: FDA, via Flickr (free of copyright protection)

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