Gavreto is a once-daily, oral precision therapy, designed to specifically act against RET alterations, fusions and mutations, irrespective of the tissue of origin
Genentech's sprawling headquarters campus in South San Francisco. (Credit: Coolcaesar/Wikipedia.)
Genentech, a subsidiary of Roche, has secured the US Food and Drug Administration (FDA) approval for Gavreto (pralsetinib) to treat a type of non-small cell lung cancer (NSCLC) in adults.
The FDA approval indicated Gavreto for treating metastatic rearranged during transfection (RET) fusion-positive non-small cell lung cancer (NSCLC), detected by an FDA approved test.
RET-activating fusions and mutations play a crucial role in various cancer types, including NSCLC and medullary thyroid cancer (MTC), and the treatment options that selectively target the genetic alterations are limitedly available.
Gavreto is a once-daily, oral precision therapy, designed to specifically act against RET alterations, including fusions and mutations, irrespective of the tissue of origin. The drug was shown to inhibit primary RET fusions and mutations, along with secondary RET mutations in the preclinical studies.
Genentech is co-developing Gavreto in partnership with Blueprint Medicines for the treatment of patients with various types of RET-altered thyroid cancers and other solid tumours.
Genentech global product development chief medical officer and head Levi Garraway said: “The FDA approval of Gavreto for RET fusion-positive non-small cell lung cancer is an important step towards our goal of providing an effective treatment option for every person diagnosed with lung cancer, no matter how rare or hard-to-treat their type of disease.
“We remain committed to finding personalized treatment options for people with cancer based on specific genomic or molecular alterations, and we look forward to partnering with Blueprint Medicines to further explore the potential of Gavreto across multiple RET-altered tumour types.”
FDA approval for Gavreto is based on data from Phase 1/2 ARROW clinical trial
The FDA has granted the approval for Gavreto under its accelerated approval programme, based on data from the Phase 1/2 ARROW clinical trial.
The study evaluated the safety, tolerability and efficacy of Gavreto in people with rearranged during transfection (RET) fusion-positive NSCLC, RET-mutant MTC, RET fusion-positive thyroid cancer and other RET-altered solid tumours.
The clinical trial is conducted in two parts, including a dose escalation portion, and an expansion portion, at multiple sites across the US, EU and Asia.
In the Phase 1/2 ARROW study showed that Gavreto has induced durable clinical responses in people with RET fusion-positive NSCLC with or without prior therapy.
The drug has demonstrated an overall response rate (ORR) of 57% and complete response (CR) rate of 5.7% in the 87 NSCLC patients, previously treated with platinum-based chemotherapy. In 27 people with treatment-naïve NSCLC, the drug showed 70% ORR and 11% CR rate.
The most common adverse reactions were fatigue, constipation, musculoskeletal pain and increased blood pressure. The median duration of response (DoR) was not reached, said the company.
Furthermore, the FDA has also granted a priority review for Gavreto to treat advanced or metastatic RET-mutant MTC and RET fusion-positive thyroid cancer, with a decision on approval expected by 28 February 2021.