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FDA

Stephen M. Hahn, MD, Confirmed as FDA Commissioner

December 12, 2019
  • Hannah Slater

Stephen M. Hahn, MD, from The University of Texas MD Anderson Cancer Center, will take over as Commissioner of the FDA, voted on by the Senate on Thursday.

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Niraparib for Advanced Ovarian Cancer with HRD+ Status Approved by FDA

October 23, 2019
  • Seth Augenstein

Niraparib was approved by the (FDA) for previously treated advanced ovarian, fallopian, or primary peritoneal cancers.

  • READ >>

FDA Grants Priority Review to Trastuzumab Deruxtecan for HER2+ Metastatic Breast Cancer

October 17, 2019
  • Seth Augenstein

The agency is set to make a decision on the investigational antibody drug conjugate by the first quarter of 2020.

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FDA Grants Breakthrough Therapy Designation to Niraparib for mCRPC

October 4, 2019
  • Seth Augenstein

The agency granted breakthrough therapy designation to niraparib for the treatment of men with BRCA1/2-mutant positive metastatic castration-resistant prostate cancer.

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Project Orbis Enables First International Approval in U.S., Canada, Australia

September 19, 2019
  • Seth Augenstein

The first-of-its-kind collaboration led to the approval of a combination therapy for patients with endometrial cancer.

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FDA Approves Apalutamide for Prostate Cancer

September 18, 2019
  • Erin Kayata

Apalutamide was initially approved in 2018 for patients with non-metastatic castration-resistant prostate cancer; the recent approval is for patients with metastatic castration-sensitive prostate cancer.

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Pembrolizumab Plus Lenvatinib Approved for Endometrial Cancer

September 17, 2019
  • Erin Kayata

The combination was simultaneously approved in Australia and Canada and was the first such action under a new international collaboration.

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Keytruda Product Image

Keytruda (Pembrolizumab) Issued New Dosage and Indication

April 22, 2019
  • Drew Boxler

The FDA has recently approved new dosage form and two new indications for the drug. 

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Bladder

Balversa Fast-Tracked for Bladder Cancer

April 12, 2019
  • David Frabotta

Erdafitinib is first targeted therapy for FGFR3 or FGFR2 genetic alteration.

  • READ >>

Resource Topics rightRail

  • Resource Topics
  • Partner Content
  • Breast Cancer
  • Acute Myeloid Leukemia
  • HER2-Positive Breast Cancer
  • Videos Breast Cancer
  • Follicular Lymphoma
Cutaneous T-Cell Lymphomas: Mycosis Fungoides and Sézary Syndrome
3 Keys to Success in the Oncology Care Model

Current Issue

ONCOLOGY Vol 33 No 11
Nov 21, 2019 Vol 33 No 11
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