Caroline Germa named CMO at Ikena Oncology

FDA grants Imfinzi priority review and Breakthrough Therapy designation for limited-stage SCLC

FDA granted priority review for Imfinzi (durvalumab), AstraZeneca’s supplemental Biologics License Application, based on the results from the positive ADRIATIC phase III trial in patients with limited-stage small cell lung cancer whose disease has not progressed following platinum-based concurrent chemoradiotherapy.

September 06, 2024

Vol.50 No.33

In Brief

Alex Morozov named chief medical officer at Pi Health

Alex Morozov was named the first chief medical officer of Pi Health, an oncology clinical trial and research technology company.

August 09, 2024

Vol.50 No.32

Clinical Trials & Tribulations

Of adaptive and factorial designs
A biostatistician’s interpretation of last week’s ODAC

At its most recent meeting, the FDA Oncologic Drugs Advisory Committee focused on perioperative clinical trials, which the agency defined as neoadjuvant phase followed by surgery and continuing with adjuvant treatment using the same experimental agent (The Cancer Letter, July 26, 2024).

Language barriers hinder diverse recruitment to clinical trials

Underrepresentation of racial and ethnic minority populations in cancer clinical trials persists partly because translation and interpretation services and resources are unavailable or inadequate in the United States, according to a Children’s Oncology Group study led by Columbia University School of Nursing.

August 02, 2024

Vol.50 No.31

Clinical Roundup

Calquence combination significantly improved PFS in CLL in phase III trial

Positive high-level results from an interim analysis of the AMPLIFY phase III trial showed a fixed duration of Calquence (acalabrutinib) in combination with venetoclax, with or without obinutuzumab, demonstrated a statistically significant and clinically meaningful improvement in progression-free survival compared to standard-of-care chemoimmunotherapy in previously untreated adult patients with chronic lymphocytic leukemia.

August 02, 2024

Vol.50 No.31

Regulatory News

ODAC vote will likely lead to three-arm and four-arm designs–and pragmatic trials–for perioperative indications

The FDA Oncologic Drugs Advisory Committee July 25 voted unanimously to set more rigorous standards for new trials for approval of perioperative indications of cancer drugs.

July 26, 2024

Vol.50 No.30

By Jacquelyn Cobb and Paul Goldberg

Caroline Germa named CMO at Ikena Oncology

YOU MAY BE INTERESTED IN

FDA grants Imfinzi priority review and Breakthrough Therapy designation for limited-stage SCLC

Alex Morozov named chief medical officer at Pi Health

Of adaptive and factorial designs
A biostatistician’s interpretation of last week’s ODAC

Language barriers hinder diverse recruitment to clinical trials

Calquence combination significantly improved PFS in CLL in phase III trial

ODAC vote will likely lead to three-arm and four-arm designs–and pragmatic trials–for perioperative indications

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Caroline Germa named CMO at Ikena Oncology

YOU MAY BE INTERESTED IN

FDA grants Imfinzi priority review and Breakthrough Therapy designation for limited-stage SCLC

Alex Morozov named chief medical officer at Pi Health

Of adaptive and factorial designsA biostatistician’s interpretation of last week’s ODAC

Language barriers hinder diverse recruitment to clinical trials

Calquence combination significantly improved PFS in CLL in phase III trial

ODAC vote will likely lead to three-arm and four-arm designs–and pragmatic trials–for perioperative indications

Can you spare 10 minutes to complete a survey?

Login

Of adaptive and factorial designs
A biostatistician’s interpretation of last week’s ODAC