When Rigel Phar­ma bought olu­tasi­denib from For­ma Ther­a­peu­tics, it ac­quired a drug that al­ready se­cured a PDU­FA date at the FDA — for Feb­ru­ary 2023. But reg­u­la­tors are ready to give their OK soon­er than that.

The FDA has ap­proved the IDH1 in­hibitor as a treat­ment for adult pa­tients with re­lapsed or re­frac­to­ry acute myeloid leukemia who have a sus­cep­ti­ble IDH-1 (isoc­i­trate de­hy­dro­ge­nase-1) mu­ta­tion as de­tect­ed by an FDA-green­lit test. Rigel will mar­ket it as Re­zlid­hia.

The OK puts Rigel in di­rect com­pe­ti­tion with Servi­er, which bought Agios’ Tib­so­vo — the first ap­proved drug in the IDH1 class — and sev­er­al oth­er IDH-tar­get­ing pro­grams as Agios of­floaded its can­cer pipeline.

Rigel tout­ed a com­pos­ite com­plete re­mis­sion (CR) and com­plete re­mis­sion with par­tial hema­to­log­i­cal re­cov­ery (CRh) rate of 35% — with a me­di­an du­ra­tion of 25.9 months.

While For­ma first de­vel­oped Re­zlid­hia, it had long deemed the drug a non-core pro­gram. Rigel paid $2 mil­lion in cash to snag full rights, and promised For­ma an­oth­er $17.5 mil­lion soon up­on meet­ing reg­u­la­to­ry, ap­proval and first com­mer­cial sales mile­stones. The rest of the $235 mil­lion deal is tied to fu­ture de­vel­op­ment and com­mer­cial work.

The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted unanimously in favor of “harmonizing” Covid vaccine compositions, meaning all current vaccine recipients would receive a bivalent vaccine, regardless of whether they’ve gotten their primary series.

The vote marks an effort to clear up confusion around varying formulations and dosing schedules for current primary series and booster vaccines, as well as “get closer to the strains that are circulating,” according to committee member Paul Offit, professor of pediatrics at the Children’s Hospital of Philadelphia.

The FDA hasn’t detected any potential safety signals, including for stroke, in people aged 65 years and older who have received Pfizer’s bivalent Covid booster, one senior official told members of the agency’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) on Thursday.

The update comes as the FDA and CDC investigate a “preliminary signal” that may indicate an increased risk of ischemic stroke in older Americans who received Pfizer’s updated shot.

The FDA has stopped use of another drug as a result of the new coronavirus variants. On Thursday, the agency announced that AstraZeneca’s antibody combo Evusheld, which was an important prevention option for many immunocompromised people and others, is no longer authorized.

The FDA said it made its decision based on the fact that Evusheld works on fewer than 10% of circulating variants.

Evusheld was initially given emergency authorization at the end of 2021. However, as Omicron emerged, so did studies that showed Evusheld might not work against the dominant Omicron strain. In October, the FDA warned healthcare providers that Evusheld was useless against the Omicron subvariant BA.4.6. It followed that up with another announcement earlier this month that it did not think Evusheld would work against the latest Omicron subvariant XBB.1.5.

Eli Lilly has succeeded in its attempt to get the first non-covalent version of Bruton’s tyrosine kinase, or BTK, inhibitors to market, pushing it past rival Merck.

The FDA gave an accelerated nod to Lilly’s daily oral med, to be sold as Jaypirca, for patients with relapsed or refractory mantle cell lymphoma.

The agency’s green light, disclosed by the Indianapolis Big Pharma on Friday afternoon, catapults Lilly into a field dominated by covalent BTK inhibitors, which includes AbbVie and Johnson & Johnson’s Imbruvica, AstraZeneca’s Calquence and BeiGene’s Brukinsa.

Merck’s blockbuster cancer treatment Keytruda has been handed another indication by the FDA.

The US regulator announced on Thursday that it has approved Keytruda to serve as an adjuvant treatment for non-small cell lung cancer (NSCLC), which is its fifth indication in NSCLC and 34th indication overall.

According to a Merck release, the approval is based on data from a Phase III trial, dubbed Keynote-091, which measured disease-free survival in patients who received chemotherapy following surgery. The data from Merck displayed that Keytruda cut down on the risk of disease recurrence or death by 27% versus placebo.