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A Look Back at FDA News in June

Danielle Ternyila
Published Online:4:00 PM, Mon July 2, 2018
The FDA approved several indications in the month of June, including venetoclax (Venclexta) in chronic lymphocytic leukemia (CLL) and small lymphocytic leukemia (SLL), the combination of binimetinib (Mektovi) plus encorafenib (Braftovi) in melanoma, and bevacizumab (Avastin) in ovarian cancer. The FDA also accelerated approvals for pembrolizumab (Keytruda) in cervical cancer and in primary mediastinal large B-cell lymphoma (PMBCL), while also granting priority reviews to glasdegib for acute myeloid leukemia (AML) and combination ibrutinib (Imbruvica) plus rituximab (Rituxan) for Waldenström macroglobulinemia.

Previous indications for the Orbis Paxman Hair Loss Cooling System and for the combination pembrolizumab (Keytruda) plus atezolizumab (Tecentriq) have now been expanded to include certain patients with ovarian cancer and urothelial carcinoma, respectively.

A new drug application (NDA) for talazoparib as a treatment for breast cancer was accepted, as well as a few supplemental new drug applications (sBLAs) including for carfilzomib (Kyprolis) for multiple myeloma as well as nivolumab (Opdivo) and ipilimumab (Yervoy) for non-small cell lung cancer (NSCLC).

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

Talazoparib Granted Priority Review by FDA for BRCA+ Metastatic Breast Cancer


A new drug application (NDA) for talazoparib was granted priority review for the treatment of patients with germline BRCA mutation-positive, HER2-negative locally advanced or metastatic breast cancer. Pfizer, the manufacturer of the PARP inhibitor, made the announcement on June 7.
 

Venetoclax Granted Full FDA Approval for CLL, Regardless of 17p Deletion


On June 8, a standard approval was granted by the FDA for venetoclax (Venclexta) as a treatment for patients with chronic lymphocytic leukemia (CLL) or small lymphocytic leukemia (SLL), with or without 17p depletion and after at least 1 prior line of therapy.
 

FDA Approves Addition of Survival Data to Carfilzomib Myeloma Label


A supplemental new drug application (sNDA) for carfilzomib (Kyprolis) was approved by the FDA on June 11. The sNDA suggests carfilzomib has benefit as a treatment option for patients with relapsed/refractory multiple myeloma.
 

Pembrolizumab Granted FDA Approval for PD-L1+ Cervical Cancer


An accelerated approval was granted by the FDA on June 12 to pembrolizumab for the treatment of patients with advanced, PD-L1-positive cervical cancer whose disease progressed on or after chemotherapy. This acceleration was based on results from the phase II KEYNOTE-158 trial.
 

Indication for Scalp Cooling System Expanded by FDA to Include All Solid Tumors


On June 13, the FDA expanded an indication for the Orbis Paxman Hair Loss Cooling System. The updated indication now includes the prevention of chemotherapy-related alopecia in patients with solid tumors. Previously, the indication only covered those patients with breast cancer.
 

Pembrolizumab Approved by FDA for Relapsed/Refractory PMBCL


An accelerated approval was granted on June 13 by the FDA for pembrolizumab as treatment for adults and pediatric patients with refractory primary mediastinal large B-cell lymphoma (PMBCL), or patients who had relapsed after a minimum of 2 prior lines of therapy.
 

Bevacizumab Approved by FDA to Treat Ovarian Cancer Following Surgery


Bevacizumab (Avastin) was approved by the FDA for treatment in combination with carboplatin and paclitaxel, followed by monotherapy of bevacizumab for patients with advanced ovarian cancer who have had initial surgical resection. This approval was announced on June 13.
 

FDA Updates Frontline Pembrolizumab, Atezolizumab Urothelial Carcinoma Labels to Include PD-L1 Status


The FDA updated labels on June 20 for pembrolizumab (Keytruda) and atezolizumab (Tecentriq). The 2 agents are now approved for use as frontline treatment for platinum-ineligible patients with urothelial carcinoma.
 

Application for Frontline Nivolumab/Ipilimumab in TMB-High NSCLC Accepted by FDA


On June 21, an sBLA was submitted and accepted by the FDA for the combination of nivolumab (Opdivo) and ipilimumab (Yervoy). The application suggests the combination can be used as a treatment for patients with advanced non-small cell lung cancer with tumor mutational burden ≥10 mutations per megabase.
 

Application for Adjuvant Pembrolizumab in Stage III Melanoma Accepted by FDA


A supplemental biologics license application (sBLA) was accepted by the FDA on June 25 for pembrolizumab as an adjuvant treatment for patients with resected, high-risk stage III melanoma. The agent proved to reduce risk of recurrence or death by 43% in the phase III EORTC 1325-MG/KEYNOTE-054 trial. The results were also published in the New England Journal of Medicine and presented at the 2018 AACR Annual Meeting.
 

Ibrutinib Plus Rituximab Combo Granted FDA Priority Review for Waldenstrom macroglobulinemia


The FDA granted a priority review on June 25, 2018, to an sNDA for the combination of ibrutinib and rituximab for treatment of patients with Waldenstrom macroglobulinemia in all settings. This decisions comes based off a reduction in the risk of disease progression or death of 80% compared to treatment with rituximab alone.
 

Binimetinib/Encorafenib Combo Approved by FDA for BRAF+ Melanoma


On June 27, the combination of binimetinib (Mektovi) plus encorafenib (Braftovi) was approved for patients with BRAF+ melanoma, based on the results from the COLUMBUS trial. This phase III study compared the combination to vemurafenib (Zelboraf) alone and encorafenib alone in a randomized 1:1:1 design.

 

Glasdegib Granted Priority Review by the FDA for Frontline Treatment of AML


The FDA also granted glasdegib a priority review on June 27 for the treatment of AML in the frontline setting. This decision comes based on results from the phase II BRIGHT 1003 trial where a 49.9% reduction was found in risk of death with a combination of glasdegib and low-dose cytarabine (LDAC).

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