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Noted This Week

September 23–29

Congress is set to pass a bill authorizing the FDA to collect user fees from companies that produce certain drugs and biologic products to help fund the timely review of applications for approval. The Prescription Drug User Fee Act must be reauthorized every 5 years; legislation providing for user fees was last passed in 2017, and that authorization will end at midnight on September 30.

By an 8–4 vote, the FDA's Oncologic Drugs Advisory Committee (ODAC) recommended against approving duvelisib (Copiktra; Secura Bio) for patients with chronic lymphocytic leukemia or small lymphocytic lymphoma, saying that the PI3K inhibitor lacks a favorable risk–benefit profile. Reviewing 5-year overall survival (OS) data from the DUO trial, FDA staff noted an increased risk of death and greater toxicity with duvelisib compared with ofatumumab (Arzerra; Novartis). However, Secura Bio representatives pointed to a significant difference in crossover from the ofatumumab arm to the duvelisib arm as a confounding factor. The FDA needn't follow ODAC's advice, but it usually does so.

The ODAC also recommended against approving melphalan flufenamide (melflufen; Pepaxto; Oncopeptides) by a 14–2 vote, saying that the risks outweigh its possible benefits for patients with multiple myeloma. The drug was granted accelerated approval in February 2021, but a phase III confirmatory trial found that OS was shorter among patients who received the drug than those who received a control regimen, prompting Oncopeptides to voluntarily remove the drug from the market in October 2021. However, the company rescinded its voluntary withdrawal in January to work with the FDA to interpret the most recent data with the hope of a new approval.

Researchers reported that in 17 patients with refractory multiple myeloma, a chimeric antigen receptor (CAR) T-cell therapy targeted to a G protein–coupled receptor, GPRC5D, yielded a response in 12 of them (N Engl J Med 2022;387:1196–206); six patients had a complete response. The patients had received a median of six multiple therapies before enrolling in the phase I trial, including several who had received CAR T cells targeting BCMA. The trial was inspired by preclinical research showing that, compared with normal cells, GPRC5D was particularly abundant on myeloma cells.

The NIH announced that it will launch a program to systematically investigate the function of every human gene and generate a catalog of the molecular and cellular consequences of inactivating each gene. According to the NIH, projects funded by the program will use null alleles, "versions of genes that do not make functional proteins… In the absence of making its functional protein, a given gene's function can be more readily deduced by studying the resulting biological characteristics, or phenotype." The Molecular Phenotypes of Null Alleles in Cells (MorPhiC) program will initially be funded for 5 years at a total of $42.5 million pending availability of funds.

The breast cancer organization Susan G. Komen announced the expansion of its screening and diagnostics program from nine cities to 12. Income-eligible residents in Dallas, TX, Los Angeles, CA, and Memphis, TN, can now access breast cancer screening and diagnostic services at no cost. The program has already been operating in Atlanta, GA; Fort Worth, TX; Houston, TX; Madison, WI; Marshfield, WI; Philadelphia, PA; Virginia Beach, VA; and Washington, DC.

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