FDA approves Augtyro for ROS1-positive NSCLC

FDA investigating serious risk of T-cell malignancy following BCMA-directed or CD19-directed autologous CAR T-cell immunotherapies

FDA has received reports of T-cell malignancies, including chimeric antigen receptor CAR-positive lymphoma, in patients who received treatment with BCMA- or CD19-directed autologous CAR T-cell immunotherapies.

December 01, 2023

Vol.49 No.44

Drugs & Targets

FDA approves Xtandi for non-metastatic castration-sensitive prostate cancer with biochemical recurrence

FDA approved Xtandi (enzalutamide) for non-metastatic castration-sensitive prostate cancer with biochemical recurrence at high risk for metastasis.

December 01, 2023

Vol.49 No.44

Drugs & Targets

FDA grants Breakthrough Therapy Designation to epcoritamab-bysp

FDA has granted Breakthrough Therapy Designation to epcoritamab-bysp, an investigational T-cell engaging bispecific antibody administered subcutaneously, for relapsed or refractory follicular lymphoma.

December 01, 2023

Vol.49 No.44

White House

As Biden invokes wartime powers to regulate AI, oncology braces for fundamental change

Invoking the Defense Production Act, President Joe Biden has ordered federal agencies and artificial intelligence companies to create safeguards and standards for the technology that has the capacity to uplift humankind as much as it can wreak unimaginable harm.

November 17, 2023

Vol.49 No.43

By Matthew Bin Han Ong

Conversation with The Cancer Letter

Paige’s Razik Yousfi: Biden has set expectations for AI, but details will come via federal guidelines

As a data scientist and software engineer, Razik Yousfi builds artificial intelligence models in health care. He started doing this 15 years ago, long before advanced chatbots catapulted AI into the layman’s consciousness.

November 17, 2023

Vol.49 No.43

By Matthew Bin Han Ong

Regulatory News

ODAC reviews two longest-running accelerated approvals as FDA weighs using its new authority

The FDA Oncologic Drugs Advisory Committee earlier this week was asked to review two of the slowest-moving confirmatory trials.

November 17, 2023

Vol.49 No.43

By Jacquelyn Cobb

FDA approves Augtyro for ROS1-positive NSCLC

YOU MAY BE INTERESTED IN

FDA investigating serious risk of T-cell malignancy following BCMA-directed or CD19-directed autologous CAR T-cell immunotherapies

FDA approves Xtandi for non-metastatic castration-sensitive prostate cancer with biochemical recurrence

FDA grants Breakthrough Therapy Designation to epcoritamab-bysp

As Biden invokes wartime powers to regulate AI, oncology braces for fundamental change

Paige’s Razik Yousfi: Biden has set expectations for AI, but details will come via federal guidelines

ODAC reviews two longest-running accelerated approvals as FDA weighs using its new authority

Renew today!

Subscriber content

Login