Shots:The US FDA has granted full approval to Zepzelca + Tecentriq as a 1L therapy for ES-SCLC pts whose disease remains stable after initial treatment with atezolizumab, carboplatin, and etoposideApproval was based on P-III (IMforte) trial results, showing Zepzelca + Tecentriq reduced risk of progression or death by 46% & death risk by…
Shots:Royalty Pharma has acquired a royalty interest in Amgen’s Imdelltra from BeOne Medicines for ~$950MAs per the deal, Royalty Pharma will acquire BeOne’s ~7% royalty on global Imdelltra sales for ~$950M, including $885M upfront and an option for BeOne to sell more for $65M within 12mos. The royalty, including shared sales above $1.5B…
Shots:The UK’s MHRA has approved Hetronifly (serplulimab) to treat previously untreated adults in the UK with extensive-stage small cell lung cancer (ES-SCLC)Approval were based on the global P-III (ASTRUM-005) study (n=585) across 128 trial sites, which showed a mFU of 42.4 mos. & 4-year OS rate of 21.9% with serplulimab + CT, confirming its long-term…
Shots:The US FDA has accepted sNDA & granted priority review seeking full approval of Zepzelca (lurbinectedin) + atezolizumab (Tecentriq) as a 1L therapy for ES-SCLC patients whose disease remains stable after initial treatment with atezolizumab, carboplatin, and etoposide (PDUFA: Oct 07, 2025)The sNDA was based on P-III (IMforte) trial results, showing Zepzelca +…
Shots:Roche has reported P-III (IMforte) trial data of Tecentriq + lurbinectedin as 1L maintenance therapy for ES-SCLC pts (≥18yrs)Trial assessed the regimen vs Tecentriq monotx. in ES-SCLC pts, where 660 pts received induction therapy with Tecentriq + CT (4 x 21-day cycles) & 483 pts without progression were then randomized to maintenance with…
Shots:BMS & BioNTech will co-develop & co-commercialize BioNTech’s BNT327 alone & in combination to treat solid tumors; BMS to hold MA globally excl. the US, UK, China, Turkey, & EU, where BioNTech will be the holderAs per the deal, BioNTech will receive $1.5B upfront, $2B in non-contingent annual payments through 2028 & ~$7.6B…

