ARPA-H, diversity in clinical trials bills advance through committee

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.

House passes Trump’s spending bill, which now moves to the Senate

The U.S. House of Representatives voted on the so-called “One Big, Beautiful Bill Act,” this week which included drastic, $715 billion cuts to Medicaid that will result in at least 8.6 million people losing health insurance coverage, including cancer patients and survivors.

May 23, 2025

Vol.51 No.20

By Claire Marie Porter

Cancer Policy

Legislation to increase access to breast and cervical cancer screening introduced in the Senate

Legislation aimed at increasing access to breast and cervical cancer screening was introduced May 22 in the U.S. Senate. The bipartisan Screening for Communities to Receive Early and Equitable Needed Services, or SCREENS, for Cancer Act would reauthorize the National Breast and Cervical Cancer Early Detection Program, or NBCCEDP, for fiscal years 2026 through 2030.

May 23, 2025

Vol.51 No.20

Drugs & Targets

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

ARPA-H, diversity in clinical trials bills advance through committee

YOU MAY BE INTERESTED IN

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

House passes Trump’s spending bill, which now moves to the Senate

Legislation to increase access to breast and cervical cancer screening introduced in the Senate

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

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