On August 21, 2019 Biologics by McKesson, an independent specialty pharmacy for oncology and other rare and complex therapeutic areas, was selected by Genentech as a specialty pharmacy provider for ROZLYTREK (entrectinib) for the treatment of hard-to-treat and rare NTRK fusion-positive tumors (Press release, McKesson, AUG 21, 2019, View Source [SID1234538911]).

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ROZLYTREK, approved by the FDA on August 15, 2019, is an oral therapy for the treatment of adults with ROS1-positive, metastatic non-small cell lung cancer (NSCLC). The FDA also granted accelerated approval for the treatment of adult and pediatric patients 12 years of age and older with solid tumors that have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion without a known acquired resistance mutation, are metastatic or where surgical resection is likely to result in severe morbidity and have progressed following treatment or have no satisfactory alternative therapy. In February 2019, the FDA accepted, with Priority Review, a New Drug Application (NDA) for ROZLYTREK based on findings from an integrated analysis of the phase II STARTRK-2, phase I STARTRK-1, and phase I ALKA-372-001 trials, which demonstrated a 57.4% overall response rate in patients with NTRK fusion-positive solid tumors.

"Combining comprehensive genomic profiling with targeted therapies provides patients with precision medicine to treat their specific cancer," said Ann Steagall, director of Clinical Policy, Biologics. "This represents a breakthrough in cancer treatment, and this is the first therapy of its kind offered by Biologics. We are excited to work with Genentech to help make this important new therapy available to patients."

The FDA has approved two oral oncology therapies based on tumor genetics rather than the organ of origin of the disease. VITRAKVI (larotrectinib) was approved in November of 2018 for the treatment of solid tumors that exhibited a NTRK gene fusion. Now the FDA approved ROZLYTREK for the treatment of cancers harboring not only a TRK mutation but also ROS1 and ALK mutations. This represents a paradigm shift in the oral cancer therapy landscape. By approving these therapies as "tissue agnostic," the FDA recognizes the key role mutations play in response to therapy. Historically, cell type and organ of origin have been the key drivers of therapy decision making.

Biologics is committed to and recognized for its high level of customer service as well as its innovative, high-touch and multidisciplinary patient-centric approach. Each team includes a pharmacist with in-depth knowledge of therapies, an experienced nurse and a financial counselor who is familiar with various financial assistance programs and organizations that help patients. This highly-skilled care team works together to develop individualized care plans that address each patient’s unique clinical, financial and emotional needs and streamlines communication back to the treating provider, enabling high-quality care and differentiated outcomes. In addition, the Biologics team works closely with payers to ensure patients can access the specialty medications they need.

Physicians may submit prescriptions to Biologics via phone (800.850.4306), fax (800.823.4506) or eScribe. For electronic prescribing systems, physicians may search for Biologics within their EMR system.