FDA grants accelerated approval to Iclusig + chemotherapy for newly diagnosed Ph+ ALL

At White House forum, Bertagnolli, Califf, Wegrzyn call for greater innovation in clinical trials

Leaders of three health agencies presented new initiatives focused on patient-centered research, diversity in clinical trial enrollment, and innovation in clinical research.

June 28, 2024

Vol.50 No.26

By McKenzie Prillaman

Clinical Roundup

FDA guidance provides new details on diversity action plans for clinical studies

FDA issued a draft guidance, “Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies,” to assist medical product sponsors in submitting diversity action plans to support certain clinical studies.

June 28, 2024

Vol.50 No.26

Drugs & Targets

FDA approves Epkinly for R/R follicular lymphoma

FDA approved Epkinly (epcoritamab-bysp) for the treatment of adults with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy.

June 28, 2024

Vol.50 No.26

Cancer History Project

Remembering the day 22 years ago when ODAC debated the Iressa quandary

On Sept. 24, 2002, when I showed up at a meeting of the FDA Oncologic Drugs Advisory Committee, I had a pretty good idea that the drug on the agenda—AstraZeneca’s Iressa (gefitinib)—was having a surprising effect on some patients in third-line non-small cell lung cancer.

FDA approves Keytruda combination for primary advanced or recurrent endometrial carcinoma

FDA approved Keytruda (pembrolizumab), Merck’s anti-PD-1 therapy, in combination with carboplatin and paclitaxel, followed by Keytruda as a single agent, for the treatment of adult patients with primary advanced or recurrent endometrial carcinoma.

June 21, 2024

Vol.50 No.25

Drugs & Targets

FDA clears IND application for ZW171, a 2+1 T-cell targeting bispecific antibody for mesothelin-expressing cancers

Zymeworks Inc., a clinical-stage biotechnology company developing a diverse pipeline of novel, multifunctional biotherapeutics to improve the standard of care for difficult-to-treat diseases, announced that FDA has cleared the investigational new drug application for ZW171, a novel 2+1 T-cell targeting bispecific antibody for mesothelin-expressing cancers.

June 21, 2024

Vol.50 No.25

FDA grants accelerated approval to Iclusig + chemotherapy for newly diagnosed Ph+ ALL

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At White House forum, Bertagnolli, Califf, Wegrzyn call for greater innovation in clinical trials

FDA guidance provides new details on diversity action plans for clinical studies

FDA approves Epkinly for R/R follicular lymphoma

Remembering the day 22 years ago when ODAC debated the Iressa quandary

FDA approves Keytruda combination for primary advanced or recurrent endometrial carcinoma

FDA clears IND application for ZW171, a 2+1 T-cell targeting bispecific antibody for mesothelin-expressing cancers

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