Improving on R-CHOP, ODAC votes 11:2 to move Genentech’s Polivy to the first line in diffuse large B-cell lymphoma

Federal judge nixes FDA’s LDT rule, says agency exceeded its authority

A federal judge ruled that the FDA lacks the statutory authority to regulate laboratory developed tests, finding squarely in favor of plaintiffs in the consolidated lawsuits brought by American Clinical Laboratories Association, Association for Molecular Pathology, and others. ASCP submitted an amicus brief supporting the plaintiffs.

April 11, 2025

Vol.51 No.14

Clinical Roundup

MSK and City of Hope researchers develop test using machine learning to help predict immunotherapy response in lymphoma

Researchers with Memorial Sloan Kettering and City of Hope have created a tool that uses machine learning to assess a non-Hodgkin lymphoma patient’s likely response to chimeric antigen receptor T-cell therapy before starting the treatment, according to study results published on April 1 in Nature Medicine.

April 11, 2025

Vol.51 No.14

Clinical Roundup

NK cells complexed with bispecific antibody yield high response rates in lymphoma

A novel cell therapy approach using cord blood-derived natural killer cells pre-complexed with AFM13, or acimtamig, a CD30/CD16A bispecific antibody, was safe and generated strong response rates for patients with refractory CD30-positive lymphomas, according to a new study from the University of Texas MD Anderson Cancer Center.

April 11, 2025

Vol.51 No.14

Drugs & Targets

FDA approves Vitrakvi for NTRK gene fusion-positive solid tumors

FDA granted full approval for Vitrakvi (larotrectinib), a first-in-class TRK inhibitor for the treatment of adult and pediatric patients with solid tumors that have a neurotrophic receptor tyrosine kinase gene fusion without a known acquired resistance mutation, are metastatic or where surgical resection is likely to result in severe morbidity, and have no satisfactory alternative treatments or that have progressed following treatment.

April 11, 2025

Vol.51 No.14

Drugs & Targets

FDA approves Jobevne, a bevacizumab biosimilar

FDA approved Biocon Biologics Ltd’s Jobevne (bevacizumab-nwgd), a biosimilar bevacizumab for intravenous use. Jobevne, a recombinant humanized monoclonal antibody used to treat several different types of cancer, is a biosimilar to the reference product Avastin (bevacizumab).

April 11, 2025

Vol.51 No.14

In the Archives

In an oral history now taken down by FDA, Andrew von Eschenbach recounts his stint as the head of both FDA and NCI—simultaneously

Credit: NCI/Linda BartlettIn an oral history conducted by FDA in September 2013, Andrew C. von Eschenbach recounted his eight-month stint in a dual role as both FDA acting commissioner and NCI director.

April 04, 2025

Vol.51 No.13

By Jacquelyn Cobb

Improving on R-CHOP, ODAC votes 11:2 to move Genentech’s Polivy to the first line in diffuse large B-cell lymphoma

YOU MAY BE INTERESTED IN

Federal judge nixes FDA’s LDT rule, says agency exceeded its authority

MSK and City of Hope researchers develop test using machine learning to help predict immunotherapy response in lymphoma

NK cells complexed with bispecific antibody yield high response rates in lymphoma

FDA approves Vitrakvi for NTRK gene fusion-positive solid tumors

FDA approves Jobevne, a bevacizumab biosimilar

In an oral history now taken down by FDA, Andrew von Eschenbach recounts his stint as the head of both FDA and NCI—simultaneously

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