A Look Back at FDA News in the Month of September


A look back at all the FDA news that occurred in the month of September.

FDA Places Partial Clinical Holds on 3 Nivolumab Myeloma Trials

On September 6, the FDA placed partial clinical holds on 3 trials, which are assessing nivolumab (Opdivo)-based combinations in patients with relapsed/refractory multiple myeloma.

Multiple Durvalumab Combination Trials Placed on Hold by FDA

On September 7, multiple trials in Celgene’s FUSION program, which is exploring regimens combining the PD-L1 inhibitor durvalumab (Imfinzi) with immunomodulatory and chemotherapy agents across several hematologic malignancies, was placed on clinical holds by the FDA.

FDA Accepts Rituximab Biosimilar Application for Treatment of Hematologic Malignancies

On September 11, a biologics license application (BLA) for the rituximab biosimilar Rixathon (GP2013) was accepted by the FDA, according to Sandoz (Novartis), the company developing the treatment. If it receives approval, rixathon would be indicated for follicular lymphoma, diffuse large B-cell lymphoma (DLBCL), and chronic lymphocytic leukemia (CLL), as well as for rheumatoid arthritis. The European Commssion already approved Rixathon for these indications in June.

Copanlisib Receives Accelerated FDA Approval for Follicular Lymphoma

Based primarily on findings from the phase II CHRONOS-1 trial, copanlisib (Aliqopa) received an accelerated approval from the FDA on September 13 as a treatment for patients with relapsed follicular lymphoma who have received at least 2 prior systemic therapies.

ABP-215, First Biosimilar for Cancer Treatment, Approved by FDA

On September 13, ABP-215 (bevacizumab-awwb; Mvasi), a biosimilar for bevacizumab (Avastin) developed by Amgen and Allergan, received FDA approval for the treatment of several different cancer types, making it the first biosimilar approved for the treatment of cancer.

Reduced Dose of Cabazitaxel Granted FDA Approval for mCRPC

Based on phase III results from the PROSELICA trial, the FDA approved the combination of cabazitaxel at a dose of 20 mg/m2every 3 weeks and prednisone for the treatment of patients with metastatic castration-resistant prostate cancer who previously received a docetaxel-containing regimen on September 17. In 2010, the FDA approved a dose of 25 mg/m2 every 3 weeks in this patient population.

ODAC Vote Split on Potential Approval of Adjuvant Sunitinib in High-Risk RCC

On September 18, the FDA’s Oncologic Drugs Advisory Committee (ODAC) voted 6-6 on the potential approval of sunitinib (Sutent) for use as an adjuvant therapy in patients with renal cell carcinoma (RCC) who have received nephrectomy and are at high risk of recurrence. The FDA will take this vote into consideration when determining its final approval decision, which is scheduled to be made by January 2018.

Pembrolizumab Receives FDA Approval for PD-L1+ Gastric Cancer

Based on findings from the phase II KEYNOTE-059 study, pembrolizumab was granted FDA approval on September 21 for the treatment of patients with PD-L1—positive recurrent or advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma who have received 2 or more lines of chemotherapy, including fluoropyrimidine- and platinum-containing chemotherapy, and, if appropriate, HER2/neu-targeted therapy.

Nivolumab Granted Accelerated Approval by FDA for HCC

On September 21, nivolumab (Opdivo) was given an accelerated approval by the FDA for the treatment of patients with hepatocellular carcinoma (HCC) following prior treatment with sorafenib (Nexavar). The approval was granted for patients regardless of their PD-L1 status.

Abemaciclib Approved by FDA for Use in HR+/HER2- Breast Cancer

On September 28, Abemaciclib (Verzenio) was approved by the FDA for use as a monotherapy and in a combination regimen for patients with HR-positive/HER2-negative breast cancer. As a monotherapy, the CDK4/6 inhibitor has been approved for patients with metastatic disease who have previously received endocrine therapy and chemotherapy, and as a combination, abemaciclib has been approved for use with fulvestrant for women with advanced breast cancer with disease progression following endocrine therapy.

Pertuzumab Granted Priority Review by FDA for HER2+ Breast Cancer

A supplemental biologics license application (sBLA) for pertuzumab (Perjeta) for use in combination with trastuzumab (Herceptin) and chemotherapy for the adjuvant treatment of patients with HER2-positive early breast cancer was granted a priority review by the FDA on September 29. The sBLA is based on data from the phase III APHINITY trial.

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