This article is more than 5 years old. Information may no longer be current.

Seven important FDA actions

Add topic to email alerts

Receive an email when new articles are posted on

Please provide your email address to receive an email when new articles are posted on .

Subscribe

Added to email alerts

You've successfully added to your alerts. You will receive an email when new content is published.

Click Here to Manage Email Alerts

You've successfully added to your alerts. You will receive an email when new content is published.

Click Here to Manage Email Alerts

Back to Healio

We were unable to process your request. Please try again later. If you continue to have this issue please contact customerservice@slackinc.com.

Back to Healio

The FDA has taken several actions in the past week related to oncology treatments.

HemOnc Today highlights seven of those actions that may affect your practice.

• An FDA advisory committee expressed unanimous support of ABP 215 (Amgen/Allergan), the first biosimilar candidate to bevacizumab (Avastin, Genentech) considered by FDA. Read more.
• The FDA approved a supplemental biologics license application for blinatumomab (Blincyto, Amgen) to treat children and adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia. Read more.
• The Oncologic Drug Advisory Committee unanimously expressed its support for the chimeric antigen receptor T-cell product tisagenlecleucel-T suspension (Novartis) — also known as CTL019 — for patients aged 3 to 25 years with relapsed/refractory B-cell acute lymphoblastic leukemia. Read more.
• The FDA granted orphan drug designation to entrectinib (RXDX-101, Ignyta) for the treatment of patients with NTRK fusion-positive solid tumors. Read more.
• An FDA advisory committee expressed its support for gemtuzumab ozogamicin (Mylotarg, Pfizer) as part of combination therapy for certain patients with acute myeloid leukemia. Read more.
• The FDA granted priority review to dasatinib (Sprycel, Bristol-Myers Squibb) for the treatment of children with Philadelphia chromosome-positive chronic phase chronic myeloid leukemia. Read more.
• The FDA granted priority review to abemaciclib (LY2835219, Eli Lilly) for the treatment of two subsets of patients with advanced hormone receptor–positive, HER-2–negative breast cancer. Read more.