Oncology Newsfeed

FDA Approves BRACAnalysis® CDx in Early-Stage Breast Cancer

On March 11, 2022, the U.S. Food and Drug Administration (FDA) approved Myriad Genetics, Inc.'s BRACAnalysis^® CDx test for use as a companion diagnostic to identify patients with germline BRCA-mutated (gRBCAm) human epidermal growth factor receptor 2 (HER2)-negative, high-risk, early-stage breast cancer who may benefit from Lynparza^® (olaparib) (AstraZeneca).

Read the Myriad Genetics, Inc. announcement.

Posted 3/14/2022

FDA Approves Olaparib for High-Risk Early Breast Cancer

FDA Approves Nivolumab in Combination for Early-Stage NSCLC

FDA Approves Pacritinib for Myelofibrosis

On Monday, February 28, 2022, the U.S. Food and Drug Administration (FDA) approved pacritinib for the treatment of adults with intermediate or high-risk primary or secondary (post-polycythemia vera or post-essential thrombocythemia) myelofibrosis with a platelet count below 50 × 10⁹/L.

Read CTI Biopharma's announcement.

Posted 3/1/2022

FDA Approves Ciltacabtagene Autoleucel for R/R Multiple Myeloma

On Monday, February 28, 2022, the U.S. Food and Drug Administration (FDA) approved ciltacabtagene autoleucel for the treatment of adults with relapsed or refractory (R/R) multiple myeloma after four or more prior lines of therapy, including a proteasome inhibitor, immunomodulatory agent, and an anti-CD38 monoclonal antibody.

Read Janssen's announcement.

Posted 3/1/2022

ACS National Consortium Releases Recommendations to Increase Screening

On February 16, 2022, the American Cancer Society's National Consortium for Cancer Screening and Care (ACS National Consortium) announced new cancer screening recommendations to accelerate recovery from the COVID-19 pandemic. These recommendations also look to improve the United States' ability to provide quality cancer screening and care for all.

The nine consensus recommendations include themes on:

• National partnerships
• Coordinated messaging
• Proven programs
• Quality measures
• Pandemic-related innovations
• Public trust
• Comprehensive preparedness plans
• Transdisciplinary teamwork
• Document and understand cancer disparities.

Read the full list and details of the recommendations on the ACS website.

FDA Approves FoundationOne®CDx to Identify MSI-H Solid Tumors

Foundation Medicine, Inc. announced that it received approval from the U.S. Food and Drug Administration (FDA) for the FoundationOne^®CDx to be used as a companion diagnostic to identify patients with microsatellite instability high (MSI-H) status solid tumors who may be appropriate for treatment with Merck’s Keytruda^® (pembrolizumab).

Read the Foundation Medicine announcement.

Posted 2/22/2022

Servier Announces New NDC Number for Ivosidenib

FDA Approves Tebentafusp-tebn for Unresectable or Metastatic Uveal Melanoma

On Wednesday, January 26, 2022, the U.S. Food and Drug Administration (FDA) approved tebentafusp-tebn for the treatment of HLA-A*02:01-positive adult patients with unresectable or metastatic uveal melanoma. 

Read Immunocore's announcement.

Posted 1/26/2022

FDA Approves Illuccix for Prostate Cancer Imaging

On December 20, 2021, the U.S. Food and Drug Administration (FDA) approved Illuccix^®, a kit for the preparation of gallium-68 (68Ga) gozetotide (also known as PSMA-11) injection, which is a radioactive diagnostic agent indicated for positron emission tomography of prostate-specific membrane antigen positive lesions in patients with prostate cancer with:

• suspected metastasis who are candidates for initial definitive therapy
• suspected recurrence based on elevated serum prostate-specific antigen level.