Recently FDA Okayed Gavreto (pralsetinib) for the treatment of adults with metastatic RET fusion-positive non-small cell lung cancer. Gavreto approved under the FDA’s accelerated approval program, according to the task of this program FDA allowed for earlier approval of drugs that treat serious conditions, and that fill an unmet medical need based on a surrogate endpoint.
“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,” said Levi Garraway, M.D., Ph.D., chief medical officer and head of Global Product Development. “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 tumor types.”
228,820 Cases Of Lung Cancer In the US
Statistics shows, that for lung cancer include both small cell and NSCLC. This year, an estimated 228,820 adults (116,300 men and 112,520 women) in the United States will be diagnosed with lung cancer. Lung cancer makes up about 13% of all new cancer diagnoses. However, from 2007 to 2016, the number of new lung cancer cases dropped by almost 3% annually in men and 1.5% annually in women. Non-small-cell lung carcinoma (NSCLC) is the most common type of lung cancer, accounting for 84% of all lung cancer diagnoses.
FDA approval was based on the results of testing’s Phase I/II ARROW study. This tests shows that Gavreto produced durable clinical responses in people with RET fusion-positive NSCLC with or without prior therapy, and regardless of RET fusion partner or central nervous system involvement. “Gavreto demonstrated an overall response rate (ORR) of 57% (95% CI: 46%, 68%) and complete response (CR) rate of 5.7% in the 87 people with NSCLC previously treated with platinum-based chemotherapy, and the median duration of response (DoR) was not reached (95% CI: 15.2 months, not reached). In the 27 people with treatment-naïve NSCLC, the ORR was 70% (95% CI: 50%, 86%) with an 11% CR rate,” – authors said.
Gavreto Adverse reactions:
- Lung problems (pneumonitis) occurred in 10% of patients who received Gavreto, including 2.7% with Grade 3/4, and 0.5% with fatal reactions.
- Increased blood pressure (hypertension) occurred in 29% of patients, including Grade 3 hypertension in 14% of patients. Overall, 7% had their dose interrupted and 3.2% had their dose reduced for hypertension.
- Liver problems (hepatotoxicity): Serious hepatic adverse reactions occurred in 2.1% of patients treated with Gavreto. Increased AST occurred in 69% of patients, including Grade 3/4 in 5.4% and increased ALT occurred in 46% of patients, including Grade 3/4 in 6%
- Grade ≥3 bleeding (hemorrhagic events) occurred in 2.5% of patients treated with Gavreto including one patient with a fatal hemorrhagic event.
- Impaired wound healing can occur in patients who receive drugs that inhibit the vascular endothelial growth factor (VEGF) signaling pathway.
“To date according to the information after study we can say that Gavreto a better clinical safety profile, and it boldly joins the ranks of previously approved treatments” Fierce pharma stated.