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The Cancer Letter
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Drugs & Targets

FDA approves Welireg for advanced renal cell carcinoma

FDA approved Welireg (belzutifan) for patients with advanced renal cell carcinoma following a PD-1 or PD-L1 inhibitor and a vascular endothelial growth factor tyrosine kinase inhibitor.
December 15, 2023
Vol.49 No.46
Drugs & Targets

FDA approves Iwilfin for adult and pediatric patients with high-risk neuroblastoma

FDA approved Iwilfin (eflornithine) to reduce the risk of relapse in adult and pediatric patients with high-risk neuroblastoma who have demonstrated at least a partial response to prior multiagent, multimodality therapy including anti-GD2 immunotherapy.
December 15, 2023
Vol.49 No.46
As Bertagnolli steps in, NIH and FDA reenvision clinical trials and evidence generation

As Bertagnolli steps in, NIH and FDA reenvision clinical trials and evidence generation

NIH and FDA envision transforming the way clinical trials are done across the biomedical research enterprise. 
December 08, 2023
Vol.49 No.45
By Matthew Bin Han Ong
Drugs & Targets

FDA approves Jaypirca in CLL/SLL indications

FDA approved Jaypirca (pirtobrutinib) for the treatment of adult patients with chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) who have received at least two prior lines of therapy, including a Bruton’s tyrosine kinase (BTK) inhibitor and a BCL-2 inhibitor. 
December 08, 2023
Vol.49 No.45
Drugs & Targets

FDA grants Fast Track designation to Alpha1H for non-muscle invasive bladder cancer

FDA granted Fast Track Designation for Alpha1H for the treatment of non-muscle invasive bladder cancer. Alpha1H is sponsored by Hamlet BioPharma AB. 
December 08, 2023
Vol.49 No.45
Clinical Roundup

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
As Biden invokes wartime powers to regulate AI, oncology braces for fundamental change
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
Paige’s Razik Yousfi: Biden has set expectations for AI, but details will come via federal guidelines
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

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