FDA Updates for the Week of June 12, 2023

FDA Approves Second Bispecific Antibody for Diffuse Large B-cell Lymphoma.

The FDA has given accelerated approval to Genentech’s Columvi (glofitamab-gxbm) to treat adult patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL). Large B-cell lymphoma is a fast-growing non-Hodgkin’s lymphoma (NHL) and is one of the most prevalent types of blood cancer among adults in the United States. Patients who relapse have poor outcomes.

Columvi will be available in the United States in the coming weeks. The estimated cost is about $350,000 for a fixed-duration treatment that is intended to be completed in 8.5 months (12 treatment cycles). A Genentech spokesperson said they expect Columvi will be covered by Medicare but it is too early to comment on the specifics. The spokesperson also said they are in discussions with multiple payers to determine insurance coverage of Columvi.

Columvi was approved based on data from the pivotal phase 1/2 NP30179 study. Results showed patients treated with Columvi achieved durable remission, with 56% of patients achieving an overall response and 43% of patients achieving a complete response. The most common adverse events were cytokine release syndrome (70%), musculoskeletal pain (21%), fatigue (20%) and rash (20%). CRS was generally low grade.

FDA Approves Linzess to Treat Children with Constipation.

The FDA has approved Linzess (linaclotide) as a once-daily treatment for pediatric patients ages 6 to 17 years-old with functional constipation, which affects an estimated 6 million U.S. children in this age group.

Developed by Ironwood Pharmaceuticals and AbbVie, Linzees Linaclotide is a guanylate cyclase-C (GC-C) agonist that is thought to work in two ways. It binds to the GC-C receptor locally, within the intestinal epithelium. Activation of GC-C results in increased intestinal fluid secretion and accelerated transit and a decrease in the activity of pain-sensing nerves in the intestine.

The children’s dose is 72 mcg, and Ironwood indicated that this dose is now available with access on most formularies. For adults, the recommended dose is 290 mcg for irritable bowel syndrome patients and 145 mcg for chronic idiopathic constipation patients, with an average retail cost of about $594 for 30 tablets, according to GoodRx.

The FDA approval was based on the results of a phase 3 study evaluating 328 patients 6 to 17 years of age who received Linzess 72 mcg. Linzess showed a statistically significant improvement compared with placebo in 12-week spontaneous bowel movement (SBM) frequency rate (SBMs/week), the primary endpoint. The most common adverse event was diarrhea, which occurred in 4% of Linzess-treated patients.

FDA Committee Recommends Sanofi/AstraZeneca’s RSV Vaccine for Infants.

FDA’s Antimicrobial Drugs Advisory Committee (AMDAC) voted unanimously 21 to 0 that Sanofi and AstraZeneca’s RSV prevention vaccine nirsevimab has a favorable benefit risk profile for newborns and infants born during or entering their first RSV season. The committee also voted 19 to 2 in support of nirsevimab’s favorable benefit risk profile for children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season, Sanofi said in a press release.

If approved, nirsevimab would be the first immunization specifically designed to protect all infants through their first RSV season, including those born healthy at term or preterm, or with specific health conditions that make them vulnerable to RSV disease, according to Sanofi.