(Seattle Genetics) July 16, 2019 - Seattle Genetics, Inc. and Astellas Pharma Inc. today announced submission of a Biologics License Application for accelerated approval to the U.S. Food and Drug Administration for the investigational agent enfortumab vedotin for the treatment of patients with locally advanced or metastatic urothelial cancer who have received a PD-1/L1 inhibitor and who have received a platinum-containing chemotherapy in the neoadjuvant/adjuvant, locally advanced or metastatic setting. The submission is based on results from the first cohort of patients in the EV-201 pivotal phase 2 clinical trial that were presented as a late-breaking abstract at the annual meeting of the American Society of Clinical Oncology (ASCO) in June. Enfortumab vedotin is an investigational antibody-drug conjugate (ADC) that targets Nectin-4, a protein that is highly expressed in urothelial cancers.i

(Posted: July 16, 2019)

Antibody drug conjugates (ADCs) may be the next "Big Thing" while breakthroughs in cellular therapies and combination I/Os move slowly and incrementally forward for solid tumors.

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(AstraZeneca) July 12, 2019 - AstraZeneca today announced that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to Imfinzi (durvalumab) for the treatment of small cell lung cancer (SCLC). SCLC constitutes about 15% of all lung cancer diagnoses. It is the most aggressive type of lung cancer with only 6% of patients alive after five years. The FDA grants ODD status to medicines and potential new medicines intended for the treatment, diagnosis or prevention of rare diseases or disorders that affect fewer than 200,000 people in the US.

H. Jack West, MD (Posted: July 15, 2019)

I would think Orphan Drug Designation would be more applicable in a situation in which we don't already have a chemo/immunotherapy combination approved in the last year based on a significant survival benefit in the exact same indication -- but who can figure out the FDA? Did I miss an announcement that they're working with the pharma industry to offer an employee incentive program based on number of new approvals, regardless of actual need?

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(COA) July 11, 2019 - Based on an initial review of the just announced Centers for Medicare & Medicaid Services’ (CMS) Radiation Oncology Alternative Payment Model, the Community Oncology Alliance (COA) has deep reservations and fundamental opposition to a proposed mandatory or “required” CMS Innovation Center (CMMI) model.

Thomas Marsland, MD (Posted: July 12, 2019)

COA absolutely has it right on this proposal. Mandatory participation in these proposed payment models is a non-starter for the medical community. We all support innovative programs to improve quality and cost but mandating unproven programs that potentially have dramatic effects on clinical practice and possibly effecting access to care is not acceptable. These programs should be small pilot to confirm "proof of principle" and voluntary. This is also a potential problem for the possible CAP program again being looked at for medical oncology. COA got it right !!!

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