A Look Back at FDA News in July

The FDA issued several approvals in July, including in colorectal cancer, breast cancer, prostate cancer, and acute myeloid leukemia. Several agents were also granted a priority review, including a frontline pembrolizumab combination in non—small cell lung cancer, pembrolizumab in HCC, and sacituzumab govitecan in triple-negative breast cancer.

Additionally, the indication for ribociclib (Kisqali) was expanded last month to include upfront ribociclib for use in combination with an aromatase inhibitor for the treatment of pre/perimenopausal or postmenopausal women with HR-positive/HER2-negative advanced or metastatic breast cancer, as well as the CDK 4/6 inhibitor in combination with fulvestrant for the treatment of postmenopausal women with HR-positive/HER2-negative advanced or metastatic breast cancer, in the frontline setting or after disease progression on endocrine therapy.

Here’s a look back on the FDA happenings for the month of July 2018:

Frontline Pembrolizumab Regimen Granted Priority Review by FDA for Squamous NSCLC

A supplemental biologics license application for first-line pembrolizumab (Keytruda) for use in combination with carboplatin/paclitaxel or nab-paclitaxel (Abraxane) was granted a priority review by the FDA on July 2 for the treatment of patients with metastatic squamous non—small cell lung cancer, regardless of PD-L1 expression.

Nivolumab Plus Ipilimumab Approved by FDA in MSI-H/dMMR Colorectal Cancer

On July 11, an accelerated approval was granted by the FDA for the combination of nivolumab (Opdivo) plus ipilimumab (Yervoy) for the treatment of both adult and pediatric patients, over the age of 12 years, with microsatellite instability-high or mismatch repair deficient metastatic colorectal cancer, following progression on treatment with a fluoropyrimidine, oxaliplatin, and irinotecan.    

FDA Grants Romyelocel-L RMAT Designation for Prevention of Infections in AML Patients With Neutropenia

Romyelocel-L was granted a Regenerative Medicine Advanced Therapy designation by the FDA on July 11 for the prevention of bacterial and fungal infections in patients with acute myeloid leukemia undergoing induction chemotherapy. RMAT designation holds similar advantages to breakthrough therapy designation.

Pembrolizumab Granted Priority Review by FDA for HCC

The PD-1 inhibitor pembrolizumab (Keytruda) was granted a priority review designation by the FDA on July 12 for use in previously treated patients with advanced hepatocellular carcinoma, Merck, the manufacturer of the agent, announced.

Frontline Venetoclax Combo Submitted for FDA Approval in AML

On July 12, the FDA received a supplemental New Drug Application for venetoclax (Venclexta) in combination with a hypomethylating agent or low-dose cytarabine as a frontline treatment for patients with acute myeloid leukemia who are ineligible for intensive chemotherapy. The application is based on results from 2 phase Ib/II trials in this setting.

Enzalutamide Approved by FDA for Nonmetastatic Castration-Resistant Prostate Cancer

Enzalutamide (Xtandi) was approved by the FDA for the treatment of patients with nonmetastatic castration-resistant prostate cancer on July 13, based on results from the phase III PROSPER trial.

Ribociclib Granted Expanded FDA Approval in Breast Cancer

On July 18, upfront ribociclib (Kisqali) was granted approval by the FDA for use in combination with an aromatase inhibitor for the treatment of pre/perimenopausal or postmenopausal women with HR-positive/HER2-negative advanced or metastatic breast cancer. The FDA also approved the CDK 4/6 inhibitor in combination with fulvestrant for the treatment of postmenopausal women with HR-positive/HER2-negative advanced or metastatic breast cancer, in the frontline setting or after disease progression on endocrine therapy.

Sacituzumab Govitecan Granted Priority Review by FDA for TNBC

A biologics license application for sacituzumab govitecan was granted a priority review by the FDA on July 18 for the treatment of patients with metastatic triple-negative breast cancer following at least 2 prior therapies for metastatic disease, Immunomedics, the manufacturer of the antibody-drug conjugate, announced.

Atezolizumab Combo Granted Breakthrough Therapy Designation by FDA for Frontline HCC

Atezolizumab (Tecentriq) was granted a breakthrough therapy designation by the FDA on July 19 for use in combination with bevacizumab (Avastin) as a first-line treatment for patients with advanced or metastatic hepatocellular carcinoma.

Ivosidenib Granted FDA Approval for IDH1+ AML

On July 20, ivosidenib (Tibsovo) was granted approval by the FDA for the treatment of adult patients with relapsed/refractory IDH1-mutant acute myeloid leukemia, based on a single-arm study of 174 patients with IDH1-positive relapsed/refractory AML.

Second Filgrastim Biosimilar Granted FDA Approval

Filgrastim-aafi (Nivestym), a filgrastim (Neupogen) biosimilar, was approved by the FDA on July 24 to treat side effects associated with cancer treatment, including febrile neutropenia and severe neutropenia, according to an announcement from Pfizer, the manufacturer of the biosimilar.

FDA Approves Magnetic System for Guiding Lymph Node Biopsy in Breast Cancer

Magtrace and Sentimag Magnetic Localization System, which uses magnetic detection to identify sentinel lymph nodes for surgical removal in women undergoing mastectomy for breast cancer, gained approval from the FDA on July 26.

Iobenguane I-131 Receives FDA Approval for Rare Neuroendocrine Tumors