Repurposed drug has promising efficacy in shrinking NSCLC tumors

ODAC marathon: Committee charges through a pileup of clinical questions in a two-day, four-application session

In two back-to-back, all-day meetings, the FDA Oncologic Drugs Advisory Committee considered four thorny applications that the agency appeared to have been saving up as a result of the pause in activity that followed President Trump’s return to office.

FDA grants accelerated approval to avutometinib + defactinib for KRAS-mutated recurrent low-grade serous ovarian cancer

FDA has approved Avmapki Fakzynja Co-Pack (avutometinib capsules; defactinib tablets) for the treatment of adult patients with KRAS-mutated recurrent low-grade serous ovarian cancer who received prior systemic therapy. Avmapki Fakzynja Co-Pack is the first and only FDA-approved medicine for this disease.

May 23, 2025

Vol.51 No.20

Podcast The Directors

The Directors: Tom Lynch and Skip Burris on how NIH funding cuts imperil biopharma innovation—and cost patient lives
In a time of uncertainty, “react to the knowns, not the fear”

Thomas J. Lynch Jr. and Howard A. “Skip” Burris III lead two institutions that couldn’t be more different—an NCI-designated Comprehensive Cancer Center on one side of the country and a for-profit research enterprise on the other—but they stay up at nights worrying about the same thing.

New compound targets circadian clock machinery in cells to fight glioblastoma

A series of preclinical studies show that a new compound, SHP1705, targets circadian clock proteins hijacked by glioblastoma stem cells, impairing the cancer cells’ ability to survive and grow.

May 16, 2025

Vol.51 No.19

Clinical Roundup

Durvalumab regimen demonstrates improvement in DFS for high-risk NMBIC in phase III trial

Positive high-level results from the POTOMAC phase III trial showed one year of treatment with Imfinzi (durvalumab) plus standard-of-care BCG induction and maintenance therapy demonstrated a statistically significant and clinically meaningful improvement in disease-free survival for patients with high-risk non-muscle-invasive bladder cancer compared to BCG induction and maintenance therapy alone.

May 09, 2025

Vol.51 No.18

Clinical

Kelly Spill opted for dostarlimab trial, avoiding rectal cancer treatment that would leave her infertile
Six years later, she is well—and pregnant with her third child

When Kelly Spill was eight months pregnant, she experienced some constipation and noticed blood in her stool. Her OBGYN wasn’t worried.

May 02, 2025

Vol.51 No.17

By Jacquelyn Cobb

Repurposed drug has promising efficacy in shrinking NSCLC tumors

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ODAC marathon: Committee charges through a pileup of clinical questions in a two-day, four-application session

FDA grants accelerated approval to avutometinib + defactinib for KRAS-mutated recurrent low-grade serous ovarian cancer

The Directors: Tom Lynch and Skip Burris on how NIH funding cuts imperil biopharma innovation—and cost patient lives
In a time of uncertainty, “react to the knowns, not the fear”

New compound targets circadian clock machinery in cells to fight glioblastoma

Durvalumab regimen demonstrates improvement in DFS for high-risk NMBIC in phase III trial

Kelly Spill opted for dostarlimab trial, avoiding rectal cancer treatment that would leave her infertile
Six years later, she is well—and pregnant with her third child

Renew today!

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Repurposed drug has promising efficacy in shrinking NSCLC tumors

YOU MAY BE INTERESTED IN

ODAC marathon: Committee charges through a pileup of clinical questions in a two-day, four-application session

FDA grants accelerated approval to avutometinib + defactinib for KRAS-mutated recurrent low-grade serous ovarian cancer

The Directors: Tom Lynch and Skip Burris on how NIH funding cuts imperil biopharma innovation—and cost patient livesIn a time of uncertainty, “react to the knowns, not the fear”

New compound targets circadian clock machinery in cells to fight glioblastoma

Durvalumab regimen demonstrates improvement in DFS for high-risk NMBIC in phase III trial

Kelly Spill opted for dostarlimab trial, avoiding rectal cancer treatment that would leave her infertileSix years later, she is well—and pregnant with her third child

Never miss an issue!

Login

The Directors: Tom Lynch and Skip Burris on how NIH funding cuts imperil biopharma innovation—and cost patient lives
In a time of uncertainty, “react to the knowns, not the fear”

Kelly Spill opted for dostarlimab trial, avoiding rectal cancer treatment that would leave her infertile
Six years later, she is well—and pregnant with her third child