Posted from: Thursday, September 19, 2019 - 09:47 AM - Present

Rozlytrek Approved to Treat Two Rare Forms of Cancer

August 15, 2019 – The U.S FDA has approve Rozlytrek™ (entrectinib), manufactured by Genentech, to treat adults who have ROS1-positive, metastatic non-small cell lung cancer (NSCLC), as well as adults and children at least 12 years of age who have certain types of solid tumors. The tumors must have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion without a known acquired resistance mutation, must be metastatic or of a nature where surgical resection is likely to result in severe morbidity, and must have progressed following treatment or have no satisfactory alternative therapy.

More than 228,000 people in the United States are expected to be diagnosed with lung cancer in 2019, with NSCLC account for 84% of all lung cancers. The ROS1 gene fusion occurs most often in young patients who have never smoked, though it can occur in anyone who is diagnosed with NSCLC. NTRK gene fusion-positive cancer occurs when the NTRK1/2/3 genes fuse with other genes. This alters proteins that can contribute to the development of certain type of cancer cells. This type of fusion can occur in tumors located anywhere in the body, no matter the cancer’s site of origin, and has been observed in wide range of cancers, including: breast, cholangiocarcinoma, colorectal, gynecological, neuroendocrine, non-small cell lung, salivary gland, pancreatic, sarcoma, and thyroid cancers.

In clinical studies, Rozlytrek was successful in shrinking the tumors of 78% of patients who had ROS1-positive, metastatic NSCLC, with a duration of response ranging from 1.8 to more than 38.6 months. It also shrank the tumors of more than half of patients with NTRK gene fusion-positive, locally advanced or metastatic solid tumors. An objective response was observed across 10 tumor times, including in individuals with central nervous system metastases, with the duration of response ranging from 2.8 to more than 26 months. Rozlytrek is the first FDA-approved treatment that targets both ROS1 and NTRK and produces a response in cancer that has spread to the brain.

Recommended dosing is 600mg per day for ROS1-positive, metastatic NSCLC and for adults who have NTRK gene fusion-positive solid tumors. For pediatric patients who have NTRK gene fusion-positive solid tumors, recommended dosing is based on body surface area and ranges from 400mg to 600mg once daily.

Rozlytrek has been launched in 100mg and 200mg capsules at a wholesale acquisition cost (WAC) of $16,800 per month at the 600mg per day dose.

Last Updated Saturday, October 19, 2019 - 08:51 PM.