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.

The San Antonio Breast Cancer Symposium is taking place this week, and so far, some of the Big Pharmas are turning out new trial data about some of the biggest drugs in the space.

First off, Novartis announced that its drug, Kisqali, showed about a year of progression-free survival in patients with different types of first-line metastatic breast cancer. The CDK 4/6 drug was first approved by the FDA in 2017, setting it up in direct competition against Pfizer’s Ibrance.

Singapore has long established itself as a major hub for pharma manufacturing, and now several big players are looking to further cement their presence in the Lion City.

Takeda, Sanofi and GSK are forming a partnership with the Singapore-based Agency for Science, Technology and Research (A*STAR) and several local academic institutions, including the National University of Singapore, Nanyang Technological University, Singapore, its enterprise company called NTUitive and Singapore Institute of Technology to provide a greater boost to the manufacturing of biologics.