22 August 2019 - - US-based Biologics by McKesson, an independent specialty pharmacy for oncology and other rare and complex therapeutic areas, was selected by US-based Genentech as a specialty pharmacy provider for Rozltrek (entrectinib) for the treatment of hard-to-treat and rare NTRK fusion-positive tumors, the company said.

Rozltrek, 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 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 for Rozltrek 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.

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 Rozltrek 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 individualised 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.

Biologics by McKesson is an independent specialty pharmacy with more than 25 years of experience connecting patients to life-changing medications in oncology and other complex therapeutic areas.

Built on the foundation of deep clinical expertise and a high-touch approach to patient care, Biologics delivers seamless access and personalised engagement, so patients get the most out of the care they receive.

As part of McKesson Life Sciences, a business within McKesson Corp., Biologics harnesses unparalleled reach and connectivity across the healthcare system to connect the dots between payers, providers and biopharma, so together, they can deliver better care and outcomes for every patient.