FDA can­cels ODAC meet­ing this week as Se­cu­ra Bio pulls ac­cel­er­at­ed ap­proval

The FDA’s On­co­log­ic Drugs Ad­vi­so­ry Com­mit­tee has de­cid­ed to can­cel a planned meet­ing on Thurs­day to dis­cuss two can­cer drugs that pre­vi­ous­ly won ac­cel­er­at­ed ap­provals but failed to con­firm clin­i­cal ben­e­fit in re­quired fol­low-up tri­als or have tak­en a long time to fin­ish those tri­als.

Se­cu­ra Bio said late Tues­day af­ter­noon that it’s de­cid­ed to pull its third-line mul­ti­ple myelo­ma drug Fary­dak, first ap­proved un­der the ac­cel­er­at­ed path­way in 2015.

The com­pa­ny, which bought the drug from No­var­tis in 2019, ex­plained its de­ci­sion by say­ing, “it was not fea­si­ble for the com­pa­ny to com­plete the re­quired post-ap­proval clin­i­cal stud­ies as de­signed as part of the ac­cel­er­at­ed ap­proval process. Be­cause those stud­ies were re­quired to ver­i­fy and de­scribe the clin­i­cal ben­e­fit of the drug prod­uct, the clin­i­cal ben­e­fit of Fary­dak has not been con­firmed un­der the spe­cif­ic con­straints of the ac­cel­er­at­ed ap­proval process.”

ODAC was al­so set to dis­cuss Acrotech Bio­phar­ma’s Mar­qi­bo, a third-line drug for adult pa­tients with Philadel­phia chro­mo­some neg­a­tive acute lym­phoblas­tic leukemia. Nei­ther Acrotech nor its par­ent com­pa­ny Au­robindo has re­spond­ed to a re­quest for com­ment.

In the case of Fary­dak, No­var­tis won the ini­tial ac­cel­er­at­ed ap­proval in 2015 but said it like­ly wouldn’t start the con­fir­ma­to­ry tri­al for al­most three years, and the FDA gave the com­pa­ny un­til this year to fin­ish both of its re­quire­ments.

In the case of Mar­qi­bo, Talon Ther­a­peu­tics ini­tial­ly won the ac­cel­er­at­ed ap­proval in 2012 based on da­ta from a sin­gle Phase II tri­al. Spec­trum Phar­ma­ceu­ti­cals then ac­quired Talon and the drug for about $11 mil­lion in 2013. In 2018, Spec­trum re­port­ed about $5.5 mil­lion in Mar­qi­bo sales, and then pro­ceed­ed to sell the drug a year lat­er with six oth­er can­cer drugs to Au­robindo Phar­ma’s sub­sidiary Acrotech for $160 mil­lion up­front.

Mean­while, Talon had ini­tial­ly agreed to sub­mit the re­sults of its con­fir­ma­to­ry tri­al to the FDA more than three years ago, but it re­mains un­known if that sub­mis­sion oc­curred.

The push to re­view these two dan­gling ac­cel­er­at­ed ap­provals fol­lowed an­oth­er ODAC meet­ing last sum­mer to re­view six oth­er in­di­ca­tions, four of which the com­mit­tee end­ed up rec­om­mend­ing re­main on the mar­ket. Since then, three in­di­ca­tions have been pulled vol­un­tar­i­ly by the com­pa­nies, and one has gone on to nab a full ap­proval.

The FDA said in a state­ment that the meet­ing “is no longer need­ed” but did not of­fer fur­ther de­tail on why ex­act­ly it was can­celed, telling End­points News to con­tact the com­pa­nies.

Ed­i­tor’s note: This ar­ti­cle has been up­dat­ed with new in­for­ma­tion from Se­cu­ra Bio.

Late Fri­day ap­proval; Trio of biotechs wind down; Stem cell pi­o­neer finds new fron­tier; Biotech icon to re­tire; and more

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Pfiz­er lays off em­ploy­ees at Cal­i­for­nia and Con­necti­cut sites

Pfizer has laid off employees at its La Jolla, CA, and Groton, CT sites, according to multiple LinkedIn posts from former employees.

The Big Pharma confirmed to Endpoints News it has let go of some employees, but a spokesperson declined to specify how many workers were impacted and the exact locations affected. Earlier this month, the drug developer had confirmed to Endpoints it was sharpening its focus and doing away with some early research on areas such as rare disease, oncology and gene therapies.

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Filip Dubovsky, Novavax CMO

No­vavax gets ready to take an­oth­er shot at Covid vac­cine mar­ket with next sea­son plans

While mRNA took center stage at yesterday’s FDA vaccine advisory committee meeting, Novavax announced its plans to deliver an updated protein-based vaccine based on new guidance.

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

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CBER Director Peter Marks (Susan Walsh/AP Images)

FDA ad­vi­so­ry com­mit­tee votes unan­i­mous­ly in fa­vor of bi­va­lent Covid shots re­plac­ing pri­ma­ry se­ries

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.

Jake Van Naarden, Loxo@Lilly CEO

Lil­ly en­ters ripe BTK field with quick FDA nod in man­tle cell lym­phoma

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.

Post-hoc analy­sis: EMA's CHMP re­jects Ipsen's po­ten­tial drug for rare ge­net­ic dis­ease

The European Medicines Agency’s Committee for Medicinal Products for Human Use on Friday rejected Ipsen Pharma’s potential treatment for a rare genetic disease known as fibrodysplasia ossificans progressiva (FOP), which causes extra bone to form outside the skeleton.

The EMA said on its website that it could not draw any firm conclusions on the benefits of the French biopharma’s Sohonos (palovarotene), which selectively targets the retinoic-acid receptor gamma (RARγ), “as the applicant’s conclusion was based on a post-hoc analysis which was neither scientifically nor clinically justified and pre-specified study objectives were not met.”

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FDA ap­proves an­oth­er in­di­ca­tion for Keytru­da, this time in the ad­ju­vant NSCLC set­ting

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.

Steve Harr, Sana Biotechnology CEO

Four years in, Sana gets first FDA go-ahead to bring can­cer treat­ment in­to the clin­ic

Sana Biotechnology is finally headed to the clinic.

Thursday afternoon, the biotech announced the FDA had cleared its application to start a clinical trial for its allogeneic, or “off-the-shelf,” CAR-T cell therapy targeting the antigen CD19 for patients with B-cell lymphomas and leukemias. Sana said its therapy, dubbed SC291, was designed to evade the immune system, which could help cell therapy produce a more durable response in patients, a concern that has followed such off-the-shelf therapies that use donor cells as opposed to a patient’s own cells.

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Eliot Forster, F-star CEO (Rachel Kiki for Endpoints News)

F-star gets down to the wire with $161M sale to Chi­nese buy­er as na­tion­al se­cu­ri­ty con­cerns linger

With the clock ticking on F-star Therapeutics’ takeover by a Chinese buyer, the companies are still scrambling to remove a hold on the deal from the US government’s Committee on Foreign Investment in the United States.

F-star and invoX Pharma said they are “actively negotiating” with CFIUS “about the terms of a mitigation agreement to address CFIUS’s concerns regarding potential national security risks posed by the transaction.”

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