The FDA has pushed back its re­view of TG Ther­a­peu­tics’ U2 com­bo (ubli­tux­imab plus Ukoniq) in pa­tients with chron­ic lym­pho­cyt­ic leukemia and small lym­pho­cyt­ic lym­phoma af­ter the drug­mak­er sub­mit­ted up­dat­ed sur­vival da­ta in Feb­ru­ary the agency deemed a ma­jor amend­ment to its ap­pli­ca­tion, ac­cord­ing to a re­lease.

The agency set a new re­view date of June 25, TG said.

The news wasn’t un­ex­pect­ed giv­en some of TG’s re­cent com­ments. In a state­ment, CEO Michael Weiss had this to say:

As men­tioned on our earn­ings call ear­li­er this week, we be­lieved an ex­ten­sion of the PDU­FA date was a like­ly sce­nario es­pe­cial­ly giv­en the pro­posed tim­ing of the up­com­ing ODAC meet­ing. We hope this ex­ten­sion pro­vides the time need­ed to give prop­er at­ten­tion and re­view to the U2 BLA/sN­DA.

With its re­view date pushed out, TG is now star­ing di­rect­ly at an up­com­ing ad­comm for U2’s ap­pli­ca­tion here, which the FDA called back in No­vem­ber. The agency at the time in­di­cat­ed to the biotech that it had more ques­tions on the OS end­point and safe­ty da­ta in the piv­otal Phase III study un­der­gird­ing its ap­pli­ca­tion.

In an up­date Thurs­day, TG said the FDA had sent a list of po­ten­tial ques­tions for that ad­comm, for which a date still hasn’t been sched­uled. Here’s what the com­pa­ny said could be on the dock­et:

The FDA has no­ti­fied the Com­pa­ny that po­ten­tial ques­tions and dis­cus­sion top­ics for the ODAC in­clude: the ben­e­fit-risk of the U2 com­bi­na­tion in the treat­ment of CLL or SLL, and the ben­e­fit-risk of Ukoniq in re­lapsed/re­frac­to­ry mar­gin­al zone lym­phoma (MZL) or fol­lic­u­lar lym­phoma (FL). In ad­di­tion, as part of the ben­e­fit-risk analy­sis, the over­all safe­ty pro­file of the U2 reg­i­men, in­clud­ing ad­verse events (se­ri­ous and Grade 3-4), dis­con­tin­u­a­tions due to ad­verse events, and dose mod­i­fi­ca­tions, is ex­pect­ed to be re­viewed. The FDA’s con­cern giv­ing rise to the ODAC meet­ing ap­pears to stem from an ear­ly analy­sis of over­all sur­vival from the UNI­TY-CLL tri­al.

Incyte touted an accelerated approval for its PD-1 retifanlimab in a rare skin cancer on Wednesday, roughly a year and a half after the drug suffered a rejection in squamous cell carcinoma of the anal canal (SCAC).

Retifanlimab, marketed as Zynyz, was approved for metastatic or recurrent locally advanced Merkel cell carcinoma (MCC), a fast-growing skin cancer typically characterized by a single, painless nodule. It’s roughly 40 times rarer than melanoma, according to the nonprofit Skin Cancer Foundation — but incidence is growing, particularly among older adults, Incyte said in its announcement.

Dupixent, the blockbuster anti-inflammatory drug from Sanofi and Regeneron, has cleared a high-stakes Phase III study in chronic obstructive pulmonary disease, the companies announced Thursday morning.

If they hold up in a second, identical trial, the data pave the way for Dupixent to become the first biologic to treat patients whose COPD remains uncontrolled despite being on maximal standard-of-care inhaled therapy — the patient population studied in the pivotal program. The companies had spotlighted this as a key readout as they look to expand the Dupixent franchise and explore its full potential.