Articles

Chicago, IL—At ASCO 2019, the FDA announced an oncology-specific pilot program for physicians and patients who are seeking access to investigational therapies. The expanded access pilot program is a concierge service, said Richard Pazdur, MD, Director, FDA’s Oncology Center of Excellence, who spoke at a press conference where the new program—Project Facilitate—was announced.

Approximately 40% of patients with hormone receptor (HR)-positive, HER2-negative breast cancer have mutations in the PIK3CA gene. Although endocrine­based therapy is the standard treatment, acquired resistance remains a challenge.

Chicago, IL—BLU-667, a novel inhibitor of RET, elicited responses in more than 50% of patients with RET fusion–positive advanced non–small-cell lung cancer (NSCLC), according to data from an ongoing phase 1 clinical trial presented at ASCO 2019.

Chicago, IL—Expanded data from an early phase 1/2 clinical trial showed that treatment with repotrectinib, an investigational tyrosine kinase inhibitor (TKI) with potent selectivity against tumors with ROS1 rearrangement, induced a response in 9 of 11 patients with TKI-naïve, advanced non–small-cell lung cancer (NSCLC) and ROS1 fusion.

Chicago, IL—With 475 cell and gene therapy companies in North America representing a business enterprise with approximately $20 billion, new immunotherapies are moving rapidly from the laboratory to the clinic. As chimeric antigen receptor (CAR) T-cell therapy makes its way from the academic to community setting, however, appropriate resources and infrastructure are required to ensure the safe and effective management of patients.

Chicago, IL—Reprogramming patients’ immune cells to treat their cancer has become the front line of cancer therapy, with chimeric antigen receptor (CAR) T-cell therapy now approved by the FDA for several blood cancers. But translating this success to solid tumors remains a challenge. At ASCO 2019, ­Gianpietro Dotti, MD, Cancer Cellular Immunotherapy Program, Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, discussed efforts to extend the application of CAR T-cell therapy to solid tumors

On June 10, 2019, the FDA granted accelerated approval to polatuzumab vedotin-piiq (Polivy; Genentech), a CD79b-directed antibody–drug conjugate, in combination with bendamustine (Bendeka, Treanda) plus rituximab (Rituxan or a biosimilar), for the treatment of patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who have received ≥2 lines of therapy. The FDA granted polatuzumab breakthrough therapy and orphan drug designations.

On May 28, 2019, the FDA approved lenalidomide (Revlimid; Celgene), in combination with rituximab (Rituxan), for the treatment of patients with previously treated follicular lymphoma or marginal-zone lymphoma (MZL). The FDA used its priority review program for this approval, and granted lenalidomide plus rituximab an orphan drug designation for this new indication.

AVBCC is delighted to announce that Scott Gottlieb, MD, former US Food and Drug Administration Commissioner, will be the keynote speaker at the 2019 AVBCC Summit on Thursday, October 17, in New York City. He will share insights he has gained over his long career at the forefront of healthcare change with the AVBCC Summit attendees.