September 08, 2020
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FDA approves Gavreto for lung cancer subset

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The FDA granted accelerated approval to pralsetinib for the treatment of adults with metastatic RET fusion-positive non-small cell lung cancer.

Pralsetinib (Gavreto, Blueprint Medicines) is a once-daily oral therapy designed to target oncogenic RET alterations. Approximately 1% to 2% of patients with NSCLC have RET alterations.

The FDA based the approval on results of the phase 1/phase 2 ARROW trial, which showed efficacy of pralsetinib for patients with RET fusion-positive NSCLC regardless of prior treatment, and regardless of RET fusion partner or central nervous system involvement.

The trial included 87 patients previously treated with platinum-based chemotherapy. In this group, researchers reported an overall response rate of 57% (95% CI, 46-68), with a 5.7% complete response rate. Median duration of response was not estimable (95% CI, 15.2-not estimable).

Among 27 treatment-naive patients who were ineligible for platinum-based chemotherapy, researchers reported an ORR of 70% (95% CI, 50-86), with an 11% complete response rate. Median duration of response in this subgroup was 9 months (95% CI, 6.3-not estimable).

Vivek Subbiah, MD
Vivek Subbiah

“Targeted therapies have dramatically improved care for patients with non-small cell lung cancer driven by oncogenes, including EGFR and ALK, and the approval of the selective RET inhibitor pralsetinib ... marks another milestone in a paradigm shift toward precision medicine,” Vivek Subbiah, MD, an ARROW trial investigator and associate professor of investigational cancer therapeutics at The University of Texas MD Anderson Cancer Center, said in a Blueprint Medicines-issued press release. “Patients treated with Gavreto had durable clinical responses, with a subset achieving complete responses characterized by the resolution of all target lesions, an uncommon outcome in metastatic lung cancer. ... This approval represents an important advance with the potential to change standards of care for patients with RET fusion-positive non-small cell lung cancer, who have historically had limited treatment options.”

Pralsetinib includes warnings and precautions about interstitial lung disease/pneumonitis, hypertension, hepatotoxicity, hemorrhagic events, risk for impaired wound healing and risk for embryo-fetal toxicity.

“We applaud therapeutic advancements like Gavreto that allow lung cancer treatment to be personalized based on the molecular drivers in a person’s tumor,” Andrea Ferris, president and CEO of LUNGevity, a national nonprofit organization that funds lung cancer research, said in the release. “There are now a number of tumor-specific gene alterations that can be targeted with FDA-approved therapies, reflecting an important inflection point supporting the widespread use of comprehensive biomarker testing. At LUNGevity, we want to empower patients and their families to discuss biomarker testing with clinicians prior to initiating treatment.”