A Look Back at FDA News in the Month of July

Three Pembrolizumab Myeloma Trials Were Placed on Clinical Hold by FDA

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.

Abemaciclib Granted FDA's Priority Review for HR+/HER2- Breast Cancer

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.

Blinatumomab Granted Full Approval by the FDA for B-cell Precursor ALL

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.

Gemtuzumab Ozogamicin Recommended for Approval by ODAC for Newly Diagnosed AML

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.

ODAC Recommended Approval of Tisagenlecleucel for Relapsed/Refractory Pediatric ALL

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."

Bevacizumab Biosimilar ABP-215 Received ODAC's Unanimous Support for Range of Tumor Types

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 Approved by FDA for Early Stage HER2+ Breast Cancer

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).

Trastuzumab Biosimilar MYL-1401O Recommended for Approval by ODAC

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 Approved by FDA for Pediatric Melanoma

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.

Supplemental BLA for New Nivolumab Dosing Schedule Accepted by FDA

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.

Venetoclax Granted Breakthrough Therapy Designation by FDA for AML Subpopulation

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.

Durvalumab Granted Breakthrough Therapy Designation by FDA for NSCLC