FDA Roundup: Updated Label for Altuviiio, CRL Given to Heplisav-B

FDA Approves Updated Label for Altuviiio for Effective Bleed Protection in Children Younger than 12 Years

The FDA approved an updated label for antihemophilic factor (recombinant), Fc-VWF-XTEN Fusion Protein-ehtl (Altuviiio), now including the full results of the XTEND-Kids (NCT04759131) clinical trial. The phase 3 study demonstrated the effectiveness of once-weekly Altuviiio in providing bleed protection in pediatric patients aged younger than 12 years with hemophilia A.

Initial approval for Altuviiio was granted in February 2023. The drug, previously known as efanesoctocog alfa, is a first-in-class, high-sustained factor VIII replacement therapy indicated for both routine prophylaxis, on-demand treatment to control bleeding episodes, and perioperative management for both adults and children with hemophilia A.

The safety profile of Altuviiio in XTEND-Kids was similar to the safety profile demonstrated in the XTEND-1 clinical trial (NCT04161495). There were no serious allergic reactions, anaphylaxis, or embolic or thromboembolic events reported. The most common adverse drug reaction, present in less than 10% of participants, was fever. There were no adverse events leading to treatment discontinuation.

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FDA Issues CRL for Heplisav-B in Adults With ESRD on Hemodialyis

The FDA issued a complete response letter (CRL) to a supplemental Biologics License Application (sBLA) from Dynavax Technologies Corporation to include a 4-dose Heplisav-B vaccination [Hepatitis B Vaccine (Recombinant), Adjuvanted] regimen for adults with end-stage renal disease (ESRD) on hemodialysis. According to the agency, the company’s application did not provide sufficient data to prove the effectiveness or safety for the 4-dose regimen.

Although the submitted sBLA demonstrated clinical immunogenicity and safety data from the phase 1 HBV-24 (NCT03934736) study of a 4-dose regimen of Heplisav-B among adult patients with ESRD undergoing hemodialysis, as well as 5 other clinical trials of Heplisav-B in adults with chronic kidney disease or undergoing dialysis, the FDA determined the data to be insufficient.

In a news release, Dynavax noted that the CRL only applies to the 4-dose schedule for dialysis patients in the US. The 2-dose Heplisav-B regimen is still approved for adults 18 and older to prevent hepatitis B infection in the US, European Union, and Great Britain, and the October 2023 decision to approve the 4-dose regimen for the adult hemodialysis patient population in Europe remains unchanged.

FDA Approves Tarlatamab-dlle for Extensive-Stage Small Cell Lung Cancer

The FDA granted accelerated approval to tarlatamab-dlle (Imdelltra) for the treatment of extensive-stage small cell lung cancer (SCLC) in adults with disease progression on or after platinum-based chemotherapy. Tarlatamab-dlle, developed by Amgen, is now the first and only approved DLL3-targeting bispecific T-cell engager therapy for the aggressive form of lung cancer.

The approval of tarlatamab-dlle was based on data from the DeLLphi-301 trial (NCT05060016), in which the therapy demonstrated antitumor activity with durable objective responses and promising survival outcomes when administered as a 10 mg dose every 2 weeks. Results from the trial were published in the New England Journal of Medicine.

The label for Imdelltra includes a boxed warning for serious or life-threatening cytokine release syndrome and neurologic toxicity, including immune effector cell-associated neurotoxicity syndrome, according to the FDA. Amgen noted that the continued approval for this indication “may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).”

FDA Warns Not to Use Cue Health COVID-19 Tests

The FDA issued a warning advising the public and health care providers not to use Cue Health’s COVID-19 Tests for Home and Over-the-Counter (OTC) Use, and its COVID-19 Test intended for patient care settings, due to increased risk of false results. The announcement follows a warning letter sent by the FDA to Cue Health earlier this month after an inspection by the agency revealed the company made changes to the tests that reduced their reliability to detect SARS-CoV-2 virus.

READ MORE: FDA Updates Resource Center

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