Phase III trial shows improved PFS in treatment of CLL using pirtobrutinib

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

Clinical Roundup

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.

Sasanlimab combination significantly improves EFS in BCG-naïve, high-risk non-muscle invasive bladder cancer

Pfizer Inc. on April 26 announced results from the pivotal phase III CREST trial of sasanlimab, an investigational anti-PD-1 monoclonal antibody, in combination with standard-of-care Bacillus Calmette-Guérin as induction therapy with or without maintenance in patients with BCG-naïve, high-risk non-muscle invasive bladder cancer.

May 02, 2025

Vol.51 No.17

Phase III trial shows improved PFS in treatment of CLL using pirtobrutinib

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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

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

Sasanlimab combination significantly improves EFS in BCG-naïve, high-risk non-muscle invasive bladder cancer

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Phase III trial shows improved PFS in treatment of CLL using pirtobrutinib

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

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

Sasanlimab combination significantly improves EFS in BCG-naïve, high-risk non-muscle invasive bladder cancer

Never miss an issue!

Login

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