FDA Accelerated Approval

Three drug approvals in a sample of 24 deviated from others

DREAMM-7 findings help pave the way for Blenrep's return

Obeticholic acid (Ocaliva) may cause serious liver damage even in PBC patients without cirrhosis

Blinatumomab consolidation reduced risk of relapse by 61% versus chemotherapy alone

News, features, and commentary about cancer-related issues

New antibody indicated for previously treated, unresectable or metastatic HER2-positive disease

Yet advisors were not inclined to take back approval for bleeding reversal agent

FDA directors explained why a confirmatory trial that fails to demonstrate a cancer drug's clinical benefit doesn't necessarily signal a failed drug.

In confirmatory trial, antibody-drug conjugate failed to improve OS versus chemotherapy

Agency advisors put their foot down on shaky science for Ocaliva in primary biliary cholangitis

Canada will soon finalize policies intended to speed approvals of medical products, but some fear the erosion of standards for evidence.

Health news and commentary gathered by MedPage Today staff

Reduced 24-hour UPCR by 38.3%

For some conditions, few approved treatments exist. Without accelerated approval, the FDA is failing patients

Adagrasib plus cetuximab leads to responses in one-third of patients, median OS of 15.9 months

The move from the FDA marks the first tumor-agnostic approval of a HER2-directed therapy and antibody drug conjugate.

About half of patients responded, duration of response as long as 19 months in three trials

Mirvetuximab soravtansine-gynx (Elahere) is approved for patients with folate receptor–alpha positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer.

Givinostat is the first nonsteroidal drug approved for DMD regardless of genetic mutation

This is the first targeted treatment approved for upfront use in adults with Philadelphia chromosome-positive acute lymphoblastic leukemia.