Shots:The CHMP has recommended Opdivo + Pt-based CT as neoadj. followed by Opdivo alone as adj. treatment of adults with resectable NSCLC at high risk of recurrence & PD-L1 expression ≥1%. If approved, EC’s decision would be valid in all 30 EEA statesThe P-III (CheckMate-77T) study assessed neoadj. Opdivo + CT, followed by surgery…
Shots:The US FDA has approved Cabometyx for treatment-experienced, inoperable, LA/M, well-differentiated pancreatic NET (pNET) & extra-pancreatic NET (epNET) pts (≥12yrs.)Approval was based on P-III (CABINET) study assessing Cabometyx (60mg) vs PBO among 298 US pts (2 arms: pNET: n=99; epNET: n=199) that showed improved PFS; data was presented at ESMO 2024 & published…
Shots:The EC has approved Imfinzi monotx. for the treatment of LS-SCLC adults whose disease has not progressed after receiving Pt-based CRT; regulatory review underway in Japan & other regions
Approval was based on P-III (ADRIATIC) trial (n=730) assessing Imfinzi (1500mg, IV, Q4W) with or without Imjudo (75mg, IV, Q4W × 4 cycles) followed by…
Shots: An already established biologic treatment for SEA in the US, EU5 & Japan. Fasenra is now showing exemplary remission for the treatment of Eosinophilic Granulomatosis with Polyangiitis (EGPA) Today, at PharmaShots, we have a distinguished panel of speakers shedding light on advancements under the P-III MANDARA study and the recent publication of the study…
In an interview with PharmaShots, Philip M. Brown, MD, JD, Chief Medical Officer at Dermavant shares his views on the P-III (PSOARING 1 & 2) trials of tapinarof for the treatment of Plaque PsoriasisShots:The P-III (PSOARING 1 & 2) trials evaluate the efficacy and safety of tapinarof (1%, qd) vs vehicle-controlled cream in a ratio (2:1) in 1025 patients aged…
In a recent interview with PharmaShots, Dr. Neil Collinson, the Senior Principal Clinical Development Scientist at Genentech / Roche shares his insights and highlights on Xofluza.Shots:The P-III BLOCKSTONE study demonstrated that the proportion of household members who became symptomatically ill following infection with influenza was significantly lower in those treated preventively with Xofluza…

