FDA tells sponsors of CAR T-cell therapies to add boxed warning about secondary T-cell malignancies

Ready or not, AI-based decision support tools are entering oncology clinics
Regulators and health systems must adapt

Urologic oncologist Wayne Brisbane thought his patient might be a good candidate for focal therapy.

November 15, 2024

Engineered HSV can trigger genetic chain reaction, rearrange HSV genes during co-infection

In preclinical work recently published in Nature Communications, Fred Hutchinson Cancer Center scientists used a genetic “chain reaction” to transform herpes simplex virus DNA during an HSV infection.

November 15, 2024

Vol.50 No.43

Clinical Roundup

Wugen launches phase II study of CD7-targeted CAR T for r/r T-ALL or T-ALL/LBL

Wugen Inc., a clinical-stage U.S. biotechnology company developing allogeneic, off-the-shelf cell therapies for the treatment of hematological and solid tumor malignancies, announced it will initiate a phase II study in the first quarter of 2025 for the company’s potential first-in-class, investigational, anti-CD7 CAR T-cell therapy, WU-CART-007, in patients with relapsed or refractory T-cell acute lymphoblastic leukemia or T-cell lymphoblastic lymphoma.

November 15, 2024

Vol.50 No.43

Drugs & Targets

FDA approves Aucatzyl for adults with r/r B-cell precursor ALL

FDA approved Aucatzyl (obecabtagene autoleucel), a CD19-directed genetically modified autologous T-cell immunotherapy, for adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia.

November 15, 2024

Vol.50 No.43

Drugs & Targets

FDA approves MI Cancer Seek as a CDx test for adults and pediatric patients

FDA has approved MI Cancer Seek for use as a companion diagnostic to identify patients with cancer who may benefit from treatment with targeted therapies.

November 08, 2024

Vol.50 No.42

Regulatory News

At his 25-year “anniversary party,” Pazdur invites Califf and past FDA commissioners to talk about political interference

FDA’s cancer czar Richard Pazdur had a “silver anniversary” at the agency recently. So, he invited some guests—the commissioners he had reported to under the Democratic and Republican administrations.

November 01, 2024

Vol.50 No.41

By Claire Marie Porter

FDA tells sponsors of CAR T-cell therapies to add boxed warning about secondary T-cell malignancies

YOU MAY BE INTERESTED IN

Ready or not, AI-based decision support tools are entering oncology clinics
Regulators and health systems must adapt

Engineered HSV can trigger genetic chain reaction, rearrange HSV genes during co-infection

Wugen launches phase II study of CD7-targeted CAR T for r/r T-ALL or T-ALL/LBL

FDA approves Aucatzyl for adults with r/r B-cell precursor ALL

FDA approves MI Cancer Seek as a CDx test for adults and pediatric patients

At his 25-year “anniversary party,” Pazdur invites Califf and past FDA commissioners to talk about political interference

Renew today!

Subscriber content

Never miss an issue!

Login

FDA tells sponsors of CAR T-cell therapies to add boxed warning about secondary T-cell malignancies

YOU MAY BE INTERESTED IN

Ready or not, AI-based decision support tools are entering oncology clinicsRegulators and health systems must adapt

Engineered HSV can trigger genetic chain reaction, rearrange HSV genes during co-infection

Wugen launches phase II study of CD7-targeted CAR T for r/r T-ALL or T-ALL/LBL

FDA approves Aucatzyl for adults with r/r B-cell precursor ALL

FDA approves MI Cancer Seek as a CDx test for adults and pediatric patients

At his 25-year “anniversary party,” Pazdur invites Califf and past FDA commissioners to talk about political interference

Never miss an issue!

Login

Ready or not, AI-based decision support tools are entering oncology clinics
Regulators and health systems must adapt