Roche turns up the heat on Lil­ly with an­oth­er Gavre­to ap­proval, el­bow­ing its way in­to the thy­roid can­cer space

Roche and Blue­print Med­i­cines are con­tin­u­ing to put pres­sure on ri­vals Eli Lil­ly and Loxo, as their Gavre­to drug picked up a new ap­proval Wednes­day.

The com­pa­nies an­nounced that the FDA has giv­en the thumbs-up for Gavre­to to treat RET-mu­ta­tion and RET-fu­sion pos­i­tive thy­roid can­cers, less than three months af­ter the drug re­ceived its first ap­proval in non-small cell lung can­cer with RET fu­sions. Gavre­to is now set to ful­ly com­pete with Lil­ly’s Retev­mo af­ter the lat­ter’s brief pe­ri­od as the on­ly de­vel­op­er with an OK’ed med­i­cine for this spe­cif­ic gene al­ter­ation.

Though Roche and Blue­print fin­ished sec­ond to Lil­ly in this race, it was on­ly by a cou­ple of months. Retev­mo picked up its ap­provals all at once back in May and is still in the ear­ly stages of roll­out, net­ting rough­ly $12 mil­lion for Lil­ly in the third quar­ter this year.

Gavre­to’s new ac­cel­er­at­ed ap­proval comes from a Phase I/II study that showed an over­all re­sponse rate of 60% in 55 RET-mu­tant pa­tients with pre­vi­ous treat­ments, and an ORR of 66% in 29 RET-mu­tant pa­tients who were treat­ment-naïve. Ad­di­tion­al­ly, 8 of 9 in­di­vid­u­als with RET-fu­sion pos­i­tive tu­mors demon­strat­ed a clin­i­cal re­sponse to the drug.

In all three pa­tient pop­u­la­tions, the me­di­an du­ra­tion of re­sponse was not reached. Across all tu­mor types, the most com­mon side ef­fects were con­sti­pa­tion, hy­per­ten­sion, fa­tigue, mus­cle pain and di­ar­rhea.

Wednes­day’s ap­proval should ser­vice a much larg­er swathe of thy­roid can­cer pa­tients than in NSCLC, as about 10 to 20% of peo­ple with pap­il­lary thy­roid can­cer have RET fu­sion-pos­i­tive tu­mors and rough­ly 90% of peo­ple with ad­vanced MTC (a rare form of thy­roid can­cer) car­ry RET mu­ta­tions. That con­trasts with RET fu­sions mak­ing up on­ly about 1% to 2% of NSCLC pa­tients.

An­a­lysts now view this race as neck and neck, with Wed­bush’s David Nieren­garten say­ing Gavre­to should split the RET-al­tered thy­roid can­cer mar­ket 50/50 with Retev­mo. Cowen’s Marc Frahm ex­pects a slight­ly small­er mar­ket share for Gavre­to at 35%, not­ing that the drug’s 9% dis­con­tin­u­a­tion rate in thy­roid can­cer re­mained high­er than Retev­mo’s 5%.

Nonethe­less, Frahm projects peak Gavre­to sales to hit about $550 mil­lion per year.

Both phar­ma com­pa­nies have pinned high ex­pec­ta­tions for their re­spec­tive drugs. Roche plunked down $775 mil­lion up­front for the rights in Ju­ly — $675 mil­lion of which was in cash — and promised Blue­print as much as $927 mil­lion in mile­stone pay­ments, in ad­di­tion to roy­al­ties on sales out­side the US. Lil­ly, mean­while, bought out Loxo en­tire­ly for a 68% pre­mi­um price of $8 bil­lion in ear­ly 2019.

Scoop: Boehringer qui­et­ly shut­ters a PhII for one of its top drugs — now un­der re­view

Boehringer Ingelheim has quietly shut down a small Phase II study for one of its lead drugs.

The private pharma player confirmed to Endpoints News that it had shuttered a study testing spesolimab as a therapy for Crohn’s patients suffering from bowel obstructions.

A spokesperson for the company tells Endpoints:

Taking into consideration the current therapeutic landscape and ongoing clinical development programs, Boehringer Ingelheim decided to discontinue our program in Crohn’s disease. It is important to note that this decision is not based on any safety findings in the clinical trials.

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Alex­ion puts €65M for­ward to strength­en its po­si­tion on the Emer­ald Isle

Ireland has been on a roll in 2022, with several large pharma companies announcing multimillion-euro projects. Now AstraZeneca’s rare disease outfit Alexion is looking to get in on the action.

Alexion on Friday announced a €65 million ($68.8 million) investment in new and enhanced capabilities across two sites in the country, including at College Park in the Dublin suburb of Blanchardstown and the Monksland Industrial Park in the central Irish town of Athlone, according to the Industrial Development Agency of Ireland.

State bat­tles over mifepri­s­tone ac­cess could tie the FDA to any post-Roe cross­roads

As more than a dozen states are now readying so-called “trigger” laws to kick into effect immediate abortion bans following the overturning of Roe v. Wade on Friday, these laws, in the works for more than a decade in some states, will likely kick off even more legal battles as states seek to restrict the use of prescription drug-based abortions.

Since Friday’s SCOTUS opinion to overturn Americans’ constitutional right to an abortion after almost 50 years, reproductive rights lawyers at Planned Parenthood and other organizations have already challenged these trigger laws in Utah and Louisiana. According to the Guttmacher Institute, other states with trigger laws that could take effect include Arkansas, Idaho, Kentucky, Mississippi, Missouri, North Dakota, Oklahoma, South Dakota, Tennessee, Texas, and Wyoming.

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Fed­er­al judge de­nies Bris­tol My­er­s' at­tempt to avoid Cel­gene share­hold­er law­suit

Some Celgene shareholders aren’t happy with how Bristol Myers Squibb’s takeover went down.

On Friday, a New York federal judge ruled that they have a case against the pharma giant, denying a request to dismiss allegations that it purposely slow-rolled Breyanzi’s approval to avoid paying out $6.4 billion in contingent value rights (CVR).

When Bristol Myers put down $74 billion to scoop up Celgene back in 2019, liso-cel — the CAR-T lymphoma treatment now marketed as Breyanzi — was supposedly one of the centerpieces of the deal. After going back and forth on negotiations for about six months, BMS put $6.4 billion into a CVR agreement that required an FDA approval for Zeposia, Breyanzi and Abecma, each by an established date.

No stranger to gene ther­a­py woes, Astel­las runs in­to an­oth­er safe­ty-re­lat­ed clin­i­cal hold

Astellas Pharma, which has been at the forefront of uncovering the risks associated with gene therapies delivered by adeno-associated viruses, must take another safety alarm head-on.

The FDA has slapped a clinical hold on Astellas’ Phase I/II trial of a gene therapy candidate for late-onset Pompe disease, after investigators flagged a serious case of peripheral sensory neuropathy.

It marks the latest in a streak of setbacks Astellas has encountered since making a splashy entry into the gene therapy space with its $3 billion buyout of Audentes. But the lead program, AT132 for the treatment of X-linked myotubular myopathy (XLMTM), had to be halted more than once after a total of four patients died in the trial — and the scientific community still doesn’t have all the answers of what caused the deaths.

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Albert Bourla, Pfizer CEO (Gian Ehrenzeller/Keystone via AP Images)

Up­dat­ing the Covid-19 vac­cine: FDA of­fers a qual­i­fied thumbs-up ahead of ad­comm

The FDA’s adcomm of outside vaccine experts will meet tomorrow to discuss how to protect the US from a likely coming wave of Omicron cases in the fall and winter, and whether to deploy vaccines that specifically target the Omicron variant.

While the data so far are limited, the FDA sounded an upbeat tone in the briefing documents on Pfizer/BioNTech’s candidates, released this weekend ahead of the VRBPAC meeting.

As court case looms, Bris­tol My­ers touts la­bel ex­pan­sion for Breyanzi

As Bristol Myers Squibb braces for a court battle over a costly delay — at least for Celgene shareholders — for its CAR-T lymphoma treatment Breyanzi, the pharma giant is touting a label expansion in the second-line setting.

Breyanzi, also known as liso-cel, snagged a win on Friday in adults with large B-cell lymphoma (LBCL) who: don’t respond to chemotherapy, or relapse within 12 months; don’t respond or relapse after 12 months; or are not eligible for hematopoietic stem cell transplant after chemo due to their age or comorbidities.

Am­gen takes next step with its Chi­na am­bi­tions, out-li­cens­ing drugs to Fo­s­un Phar­ma

In a bid to increase its market share in China, Amgen has agreed to a partnership with a Shanghai biotech — a collaboration and out-licensing agreement for two of its drugs.

Amgen and Fosun Pharma announced a deal Monday in a bid to increase Amgen’s presence in the country. The stated goal so far is to commercialize Amgen’s blockbuster psoriasis drug Otezla alongside Parsabiv, a drug for secondary hyperparathyroidism in adults with chronic kidney disease and on a specific type of dialysis.

Deborah Dunsire, Lundbeck CEO

Af­ter a 5-year re­peat PhI­II so­journ, Lund­beck and Ot­su­ka say they're fi­nal­ly ready to pur­sue OK to use Rex­ul­ti against Alzheimer's ag­i­ta­tion

Five years after Lundbeck and their longtime collaborators at Otsuka turned up a mixed set of Phase III data for Rexulti as a treatment for Alzheimer’s dementia-related agitation, they’ve come through with a new pivotal trial success they believe will finally put them on the road to an approval at the FDA. And if they’re right, some analysts believe they’re a short step away from adding more than $500 million in annual sales for the drug, already approved in depression and schizophrenia.

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