2020-09-08| Trials & Approvals

GAVRETO Grabs FDA Approval for Metastatic RET Fusion-Positive NSCLC

by Tulip Chakraborty
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Mutation or alteration of one or more genes in the body is responsible for uncontrolled cell growth resulting in cancer. Lung cancer is the second most common cancer and makes up about 13% of all new cancer cases. Non-Small Cell Lung Cancer (NSCLC) is the most common form of lung cancer resulting in 84% of all the lung cancer diagnoses. It is estimated that this year (2020) approximately 116,300 men and 112,520 women will be diagnosed with lung cancer in the United States alone [1].

By T. Chakraborty, Ph.D.

RET fusions and mutations are primary disease drivers in numerous cancer types, including 1% – 2% of patients with NSCLC, 10% – 20% of patients with papillary thyroid cancer and 90% of patients with Medullary thyroid cancers (MTC). Additionally, RET fusions are prevalent in low frequencies in breast, pancreatic, colorectal among other forms of cancers, thus making it an essential protein to target. Blueprint Medicines Corporation, headquartered in Massachusetts, focuses on providing precision therapies, announced on September 4, that the U.S. Food and Drug Administration (FDA) has approved GAVRETO (pralsetinib), a once-daily oral RET-targeted therapy for adult patients with metastatic RET fusion-positive NSCLC [2].

Related article: Roche Collaborates with Blueprint Medicines to Develop Personalized Medicine for Lung and Thyroid Cancer

About the ARROW trial

FDA acceleratedly approved GAVRETO based on findings from the open-label, first-in-human phase 1/2 study, called ARROW. The patients enrolled had an overall response rate of 57%. Out of the 87 patients who were previously treated with chemotherapy, approximately 6% had a complete response rate. Around 70% of the 27 patients who had no treatment history, responded to the drug with 11% reaching complete response. Some of the most common adverse events included fatigue, constipation, hypertension, hepatotoxicity, and hemorrhagic events. Blueprint Medicines and Genentech will co-commercialize GAVRETO and make it available in the U.S. within the next one week [2].

Vivek Subbiah, M.D, associate professor of Investigational Cancer Therapeutics and center medical director of the Clinical Center for Targeted Therapy at The University of Texas MD Anderson Cancer Center, and an investigator on the ARROW trial said, “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, or GAVRETO, marks another milestone in a paradigm shift toward precision medicine. Patients treated with GAVRETO had durable clinical responses. A subset achieved complete responses characterized by the resolution of all target lesions, an uncommon outcome in metastatic lung cancer. We observed this activity with or without prior therapy and regardless of RET fusion partner or brain metastases. 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.” [2]

Jeff Albers, CEO of Blueprint Medicines added, “GAVRETO is the second breakthrough therapy discovered by Blueprint Medicines that has received FDA approval in 2020, less than 10 years since the company started operations. This progress reflects our scientific platform’s power, our focus on delivering transformative outcomes to patients and our urgency to address important medical needs. We are working with our partner Genentech to rapidly bring GAVRETO to healthcare providers and patients in the U.S., applying our complementary capabilities to support patient identification and treatment access. Ultimately, we aim to accelerate the identification of patients with RET fusion-positive non-small cell lung cancer and enable them to rapidly access GAVRETO.” [2]

The recent press release from Blueprint Medicines further added that the FDA has accepted the company’s new drug application (NDA) for GAVRETO under the FDA’s Real-Time Oncology Review (RTOR) pilot program. This pilot program investigates further efficient review processes to ensure that safe and effective treatments are available to all patients globally as soon as possible. Additionally, the FDA has also granted priority review to GAVRETO and set an action date on February 28, 2021. [2]

Related article: UK Startup Biofidelity Ltd. Acquires $12 Million in Series A Financing





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