Personalized Medicine

FDA Grants Priority Review to Keytruda for Patients with High-Risk, Non–Muscle-Invasive Bladder Cancer

Yvette Florio Lane

Bladder Cancer, FDA Approvals, News & Updates, Immunotherapy

On December 2, 2019, Merck announced that the FDA has granted priority review for its supplemental biologics license application for the anti–PD-1 agent pembrolizumab (Keytruda). If approved, the drug would be indicated as monotherapy to treat patients with Bacillus Calmette-Guerin–unresponsive, high-risk, non–muscle-invasive bladder cancer who are ineligible for or have decided not to undergo cystectomy. [ Read More ]

Patients with Medicaid or No Insurance Have Worse Survival in Clinical Trials

Chase Doyle

October 2019, Vol 10, No 5 - Clinical Trials

San Diego, CA—New research sponsored by the National Cancer Institute highlights the uphill battle faced by patients with limited financial resources even in clinical trials. According to data presented at the 2019 ASCO Quality Care Symposium, patients with Medicaid or with no insurance had significantly worse overall survival in positive clinical trials compared with privately insured patients. [ Read More ]

Neoantigens Are Effective Targets for Developing Cancer Vaccines

Wayne Kuznar

October 2019, Vol 10, No 5 - Emerging Therapies

Chicago, IL—Tumor-specific antigens provide personalized targets for immunotherapy. Neoantigen vaccines are a new type of immunotherapy that can elicit immune response and achieve remission. Evidence is compelling to support neoantigens as the target of effective immune responses against cancer and to support an association between neoantigen load with improved clinical outcome, said Patrick Alexander Ott, MD, PhD, Clinical Director, Center for Immuno-Oncology, Dana-Farber Cancer Institute, Boston, MA, at ASCO 2019. [ Read More ]

Long-Term Data Confirm Survival Benefit for Pembrolizumab in Advanced NSCLC

Phoebe Starr

October 2019, Vol 10, No 5 - Lung Cancer

Chicago, IL—Treatment with the immune checkpoint inhibitor pembroliz­umab (Keytruda) dramatically improved 5-year survival for patients with advanced non–small-cell lung cancer (NSCLC) compared with expected survival in the preimmunotherapy era, according to the 5-year follow-up data from the phase 1b KEYNOTE-001 clinical trial. The study was presented at ASCO 2019 and was published simultaneously in the Journal of Clinical Oncology. [ Read More ]

Oral Cancer and Sex in the Era of HPV Infection

Meg Barbor, MPH

October 2019, Vol 10, No 5 - Head and Neck Cancer

San Francisco, CA—The increasing rate of infection with the human papilloma­virus (HPV) in the United States has changed the field of head and neck cancer, or oral cancer, and HPV infection now causes a growing majority (70%-90%) of oropharyngeal squamous-cell carcinomas. As its incidence is rising, so is patients’ curiosity about what sets this cancer apart from other malignancies. [ Read More ]

FDA Approves Darzalex Combination for First-Line Treatment of Transplant-Eligible Patients with Multiple Myeloma

FDA Approvals, News & Updates, In the News, Multiple Myeloma

On September 26, 2019, the FDA approved daratumumab (Darzalex; Janssen) in combination with bortezomib, thalidomide, and dexamethasone for the treatment of newly diagnosed patients with multiple myeloma who are eligible for autologous stem-cell transplant (ASCT). The FDA granted this application priority review. [ Read More ]