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FDA Pipeline: Priority Reviews in Renal Cell Carcinoma and Head and Neck Cancer

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Over the past week, the U.S. Food and Drug Administration (FDA) granted multiple Priority Reviews:

Pembrolizumab in Combination With Axitinib as First-Line Treatment for Advanced Renal Cell Carcinoma

Today, the FDA accepted and granted Priority Review for a new supplemental biologics license application (sBLA) for pembrolizumab, an anti­–programmed cell death protein 1 (PD-1) therapy, in combination with axitinib, a tyrosine kinase inhibitor, for the first-line treatment of patients with advanced renal cell carcinoma. A Prescription Drug User Fee Act (PDUFA), or target action, date of June 20, 2019, has been set.

This sBLA is based on findings from the phase III KEYNOTE-426 trial, which demonstrated that pembrolizumab in combination with axitinib, as compared to sunitinib, significantly improved overall survival and progression-free-survival in the first-line treatment of advanced renal cell carcinoma. These data will be presented this weekend by Powles et al at the 2019 Genitourinary Cancers Symposium (Abstract 543). The sBLA also included supporting data from the phase Ib KEYNOTE-035 trial, which was presented by Atkins et al at the European Society for Medical Oncology (ESMO) 2016 Congress.

Avelumab Plus Axitinib for Advanced Renal Cell Carcinoma

This week, the FDA also accepted for Priority Review an sBLA for avelumab in combination with axitinib for patients with advanced renal cell carcinoma. The application has been given a target action date of June 2019.

The submission is based on data from the phase III JAVELIN Renal 101 trial, which were presented in the Presidential Symposium at the ESMO 2018 Congress by Motzer et al (Abstract LBA6_PR).

In December 2017, the FDA granted Breakthrough Therapy designation for avelumab in combination with axitimib for treatment-naive patients with advanced renal cell carcinoma.

Pembrolizumab as First-Line Treatment for Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma

Finally, this week, the FDA accepted another sBLA for pembrolizumab as monotherapy or in combination with platinum and fluorouracil (5-FU) chemotherapy for the first-line treatment of patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC). The FDA has granted Priority Review to this sBLA and set a PDUFA date of June 10, 2019.

This sBLA is based in part on data from the phase III KEYNOTE-048 trial, in which pembrolizumab demonstrated a significant improvement in overall survival compared with the standard of care as monotherapy in patients whose tumors expressed programmed cell death ligand 1 (PD-L1) with combined positive score (CPS) ≥ 20 and CPS ≥ 1, and in combination with chemotherapy in the total patient population. These data were presented by Burtness et al at the ESMO 2018 Congress (Abstract LBA8_PR).

KEYNOTE-048 also serves as the confirmatory trial for KEYNOTE-012, a phase Ib study which supported the previous accelerated approval for pembrolizumab as monotherapy for the treatment of patients with recurrent or metastatic HNSCC with disease progression on or after platinum-containing chemotherapy.

The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.


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