FDA approves Sarclisa + VRd for MM not eligible for transplant

Janet Woodcock, Paul Kim join Friends’ board of directors

Janet WoodcockPaul T. KimJanet Woodcock, former director of the Center for Drug Evaluation and Research at FDA, and Paul T. Kim, principal of Kendall Square Policy Strategies LLC, were appointed to the board of directors at Friends of Cancer Research.

January 24, 2025

Vol.51 No.03

Drugs & Targets

FDA grants RP1 BLA priority review for advanced melanoma

FDA has accepted the Biologics License Application from Replimune Group Inc. for RP1 (vusolimogene oderparepvec) in combination with nivolumab (Opdivo) for patients with advanced melanoma.

January 24, 2025

Vol.51 No.03

Drugs & Targets

EU, China approve Sarclisa + standard of care for MM

The EU has approved Sarclisa (isatuximab-irfc) in combination with a standard-of-care regimen, bortezomib, lenalidomide, and dexamethasone, for the treatment of adult patients with newly diagnosed multiple myeloma ineligible for autologous stem cell transplant, based on data from the IMROZ phase III study.

January 24, 2025

Vol.51 No.03

Guest Editorial

FDA and OHRP draft guidance aims to improve ethics of tissue biopsies in clinical trials

The U.S. Food and Drug Administration and the U.S. Department of Health and Human Services Office of Human Research Protections issued Draft Guidance on the inclusion of tissue biopsies in clinical trials.

January 17, 2025

Vol.51 No.02

By Laura A. Levit, Mark J. Ratain, Julie R. Gralow, Clifford A. Hudis and Elizabeth Garrett-Mayer

In Brief

David Chung named director of clinical research at Northwell Health

Northwell Health appointed David J. Chung, a prominent oncologist-investigator, as director of clinical research at the Northwell Health Cancer Institute. In this newly created role, Chung also will serve as system chief of multiple myeloma across Northwell’s cancer centers.

January 17, 2025

Vol.51 No.02

Drugs & Targets

FDA approves sotorasib + panitumumab for KRAS G12C-mutated colorectal cancer

FDA approved sotorasib (Lumakras) with panitumumab (Vectibix) for adult patients with KRAS G12C-mutated metastatic colorectal cancer, as determined by an FDA-approved test, who have received prior fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy.

January 17, 2025

Vol.51 No.02

FDA approves Sarclisa + VRd for MM not eligible for transplant

YOU MAY BE INTERESTED IN

Janet Woodcock, Paul Kim join Friends’ board of directors

FDA grants RP1 BLA priority review for advanced melanoma

EU, China approve Sarclisa + standard of care for MM

FDA and OHRP draft guidance aims to improve ethics of tissue biopsies in clinical trials

David Chung named director of clinical research at Northwell Health

FDA approves sotorasib + panitumumab for KRAS G12C-mutated colorectal cancer

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