Eight recent FDA actions that may affect your practice

HemOnc Today presents a summary of eight recent FDA decisions or announcements that could affect how you treat your patients.

Blinatumomab (Blincyto, Amgen) received priority review for treatment of pediatric and adolescent patients with Philadelphia chromosome-negative relapsed or refractory B-cell precursor acute lymphoblastic leukemia. A phase 2 trial that included patients aged younger than 18 years met its primary endpoint of complete remission within the first two cycles. Read more
The FDA granted priority review to olaratumab (LY3012207, IMC-3G3; Eli Lilly and Company) in combination with doxorubicin to treat patients with advanced soft tissue sarcoma who are not responsive to curative treatment with radiotherapy or surgery. The biologics license application included results from a pivotal phase 2 open-label, randomized trial. Read more
As part of its “This Free Life” initiative, the FDA launched a public education campaign designed to prevent or reduce tobacco use among young adults who identify as lesbian, gay, bisexual or transgender. The campaign targets those aged 18 to 24 years who are social or casual smokers. Read more
The FDA extended its regulatory authority over all tobacco products, including e-cigarettes, cigars and hookah tobacco. The FDA’s action will allow for establishment of federal provisions that prohibit retailers from selling these products to individuals aged younger than 18 years. Read more
The FDA approved cabozantinib (Cabometyx, Exelixis) for treatment of patients with advanced renal cell carcinoma who received prior antiangiogenic therapy. Read more
Nivolumab (Opdivo, Bristol-Myers Squibb) received breakthrough therapy designation for the treatment of patients with recurrent or metastatic squamous cell carcinoma of the head and neck who previously received platinum-based therapy. The FDA based the designation on results of the phase 3 Checkmate -141 trial, an open-label, randomized trial. Read more
Venetoclax (Venclexta; AbbVie, Genentech) became the first FDA–approved therapy that targets the BCL-2 protein, which supports cancer cell growth and often is overexpressed in chronic lymphocytic leukemia. It is indicated for patients with CLL who have deletion of chromosome 17p and have received at least one prior therapy. Read more
The FDA granted priority review to pembrolizumab (Keytruda, Merck) for single-agent treatment of patients with recurrent or metastatic head and neck squamous cell carcinoma whose disease progressed on or after platinum-containing chemotherapy. Read more