Five for the First Quarter: What will FDA approve?
Experts think that FDA’s busy approval pace in 2021 will continue into the first quarter of 2022. Last year’s approvals included 50 new medicines, including treatments for cancer, high cholesterol, HIV and, most controversially, Alzheimer's disease. Here are five likely approvals to watch:
Eli Lilly/Innovent sintilimab for lung cancer
Eli Lilly and Innovent Biologics' would-be immunotherapy sintilimab was developed and exclusively tested in China. Lilly acquired rights to sintilimab, marketed in China as Tyvyt, from China's Innovent, and now hopes to win U.S. approval without having to run a head-to-head study against an established checkpoint inhibitor. Tyvyt was tested against chemotherapy alone in the trial supporting its application.
Two of the FDA's top cancer drug officials have said that such a study would "probably be required" in such a scenario. They also said that the results of a clinical trial conducted overseas must be generalizable to the U.S. population. The agency is holding an advisory meeting on Lilly's application on February 10, and the implications are significant for the company and others.
Bristol Myers Squibb relatlimab for melanoma
By March 19, relatlimab could be a third cancer-fighting checkpoint inhibitor approved by the FDA as the agency is set to decide on an immunotherapy developed by Bristol Myers. The drug is aimed at a different cellular target than earlier checkpoint inhibitors: those treatments work by blocking the proteins known as CTLA-4, PD-1 or PD-L1, but relatlimab focuses on one called LAG-3. The idea is similar: by blocking these proteins, immunotherapy helps cancer-fighting immune cells target and attack tumor cells.
Approval would be important for both the immunotherapy field and for Bristol Myers. In clinical trials, combining relatlimab with Opdivo significantly reduced the risk of cancer progression over Opdivo alone in people whose melanoma had either spread or could not be surgically removed. The results were the first definitive proof that targeting LAG-3 can be beneficial, and the first time a treatment regimen had been shown to improve on
Opdivo.
Gilead lenacapavir for HIV
While Gilead has had the world's leading business for HIV treatment, a drug called lenacapavir has become important to Gilead's future. Lenacapavir is designed to attach to the capsid — the shell that encases the virus' genetic information — and stop it from breaking apart, thus impeding the HIV replication process.
Gilead has had positive clinical trial results showing that lenacapavir helped to suppress HIV in patients who had tried multiple other therapies but were no longer responding to them. About 80 percent of patients evaluated had viral loads so low that they were undetectable six months after starting treatment with lenacapavir and an optimized background regimen. A decision from the FDA on approval is expected by February 28; that would make the drug the first capsid inhibitor ever cleared for market, and the only HIV treatment option given every six months.
Akebia vadadustat for anemia in CKD
A group of pills known as HIF-PH inhibitors were supposed to facilitate anemia care for people with failing kidneys, but Akebia Therapeutics’ vadadustat appeared to have cardiovascular risk issues. HIF-PH blockers could still have a future in the U.S., however.
In November, GlaxoSmithKline showed positive Phase 3 results for its drug daprodustat, which is approved overseas. Akebia has moved forward with an approval application, arguing the totality of its study results are good enough to secure regulatory clearance. Some people think the FDA will approve it for those on dialysis, a sizable market. The agency will decide by March 29.
AstraZeneca/Merck Lynparza for early breast cancer
Lynparza, a type of cancer medicine known as a PARP inhibitor, has won approvals in multiple tumor types and becoming a multibillion dollar drug, and now its manufacturers are seeking FDA approval for early use in a particularly aggressive, hereditary form of breast cancer. In a 2021 Phase 3 trial, Lynparza helped slow the return of HER2-negative tumors in women with an inherited mutation to the genes BRCA1 or BRCA2, which account for about 5 percent of all breast cancer cases.
Lynparza was used as an "adjuvant" treatment after surgery to remove a tumor and other standard drugs like chemotherapy. Treatment helped patients with both local as well as distant tumors. If cleared, Lynparza would also become the latest high-priced cancer medicine to move into an earlier setting.