A look back at all the FDA news that occurred in July.
On July 7, the FDA ordered a clinical hold to be placed on the phase III KEYNOTE-183 and KEYNOTE-185 pembrolizumab (Keytruda) trials and the discontinuation of the lenalidomide/dexamethasone/ pembrolizumab arm of the KEYNOTE-023 trial. All 3 studies were evaluating the PD-1 inhibitor in patients with multiple myeloma.
A new drug application (NDA) for abemaciclib was granted a priority review by the FDA on July 10 as a treatment for patients with advanced hormone receptor (HR)positive, HER2-negative breast cancer, according to Eli Lilly and Company, the manufacturer of the CDK4/6 inhibitor.
On July 12, blinatumomab (Blincyto) was granted a full approval by the FDA as a treatment for adults and children with relapsed/refractory B-cell precursor acute lymphoblastic leukemia (ALL), regardless of Philadelphia chromosome (Ph) status, according to the developer of the anti-CD19 immunotherapy, Amgen.
In a 6-1 vote, the FDA’s Oncologic Drugs Advisory Committee (ODAC) voted in favor of approving gemtuzumab ozogamicin (Mylotarg) in combination with daunorubicin and cytarabine for the treatment of patients with newly-diagnosed CD33-positive acute myeloid leukemia (AML) on July 12.
On July 12, the Oncologic Drugs Advisory Committee (ODAC) voted 10-0 to recommend approval of a biologics license application (BLA) for tisagenlecleucel (CTL019) for the treatment of patients aged 25 or younger with relapsed/refractory B-cell acute lymphoblastic leukemia (ALL), citing “unprecedented clinical success” and calling the drug “potentially paradigm-changing."
In a 17-0 vote, the FDA’s Oncologic Drugs Advisory Committee unanimously recommended the approval of ABP-215, a biosimilar for bevacizumab (Avastin) manufactured by Amgen and Allergan, to treat a range of solid tumors on July 13.
Neratinib (Nerlynx) was approved by the FDA on July 17 for the extended adjuvant treatment of patients with early stage HER2-positive breast cancer following postoperative treatment with trastuzumab (Herceptin).
On July 19, MYL-1401O, the trastuzumab (Herceptin) biosimilar manufactured by Mylan Pharmaceuticals, was recommended for approval by the FDA's Oncologic Drugs Advisory Committee (ODAC) in a 16-0 vote.
Ipilimumab (Yervoy) was approved by the FDA on July 24 for the treatment of patients aged ≥12 years with unresectable or metastatic melanoma, according to Bristol-Myers Squibb (BMS), the manufacturer of the CTLA-4 inhibitor.
On July 27, supplemental Biologics License Applications (sBLAs) were sent to and accepted by the FDA for a new dosing schedule for nivolumab (Opdivo) across all of the agent's indications as a montherapy, according to Bristol-Myers Squibb (BMS), the manufacturer of the PD-1 inhibitor.
On July 31, the FDA granted breakthrough therapy designation to venetoclax (Venclexta) for use in combination with low dose cytarabine (LDAC) in treatment-naïve elderly patients with acute myeloid leukemia (AML) who are ineligible for intensive chemotherapy, according to Roche, which is codeveloping the BCL-2 inhibitor with AbbVie.