Skip to content Skip to footer

NEWS

Novocure
Novocure Reports Topline P-II (PANOVA-4) Trial Data on TTFields Therapy for Metastatic Pancreatic Ductal Adenocarcinoma (mPDAC)
Shots: Novocure reported P-II (PANOVA-4) trial data evaluating Tumor Treating Fields (TTFields) with Tecentriq & gemcitabine/nab-paclitaxel as a 1L treatment for mPDAC, with a median TTFields duration of 25.6wks. & median systemic therapy duration of 6 cycles Trial met its 1EP, showing a DCR of 74.4% in TTFields group (N=78) vs 48% with gem/nab-pac alone…
Kallisio’s Stentra Receives CE Mark for Precision Oral Immobilization System in Head & Neck Radiation Therapy
Shots: Kallisio has received CE certification under the EU MDR 2017/745 for its Stentra intraoral positioning system, with initial deployment planned through selected clinical pilot sites in Germany Stentra is a patient-specific intraoral device designed to support precise positioning & stabilization during head & neck radiation therapy, integrating seamlessly into existing workflows without requiring changes…
Amgen
The CHMP Recommends Amgen’s Imdylltra to Treat 1L ES-SCLC   
Shots:  The CHMP has recommended Imdylltra (tarlatamab) as a monotx. to treat adults with extensive-stage small cell lung cancer (ES-SCLC) whose disease relapsed during or after an initial treatment with Pt-based CT  Opinion was based on the P-III study in 509 ES-SCLC pts post Pt therapy, where Imdylltra showed improved mOS (13.6 vs 8.3 mos.; ~40% lower death risk) and higher mPFS (4.2 vs 3.2 mos.) vs SoC  Imdylltra is…
Sanofi
Sanofi Reports the EC Approval of Rezurock (Belumosudil) to Treat Chronic Graft-vs-Host Disease (GVHD) 
Shots:  The EC has approved Rezurock (200mg) to treat chronic GVHD pts (≥12yrs., ≥40kg)  Approval was based on safety and efficacy clinical data, incl. the P-II (ROCKstar) trial (n=77), which showed an improved ORR of 74% in chronic GVHD pts post–stem cell transplant & after ≥2 prior systemic therapies  Under the conditional marketing authorisation, Sanofi will conduct a confirmatory randomized study Ref:…
UCB Reports the EC Approval of Kygevvi for Thymidine Kinase 2 Deficiency (TK2d) 
Shots:  The EC has approved kygevvi (doxecitine and doxribtimine) under exceptional circumstances for adults & pediatric pts with TK2d whose symptom onset occurred ≤12yrs. of age  Supportive evidence for approval came from pooled data from 2 studies of Kygevvi in pts with genetically confirmed TK2d & symptom onset ≤12yrs. The studies showed improved functional outcomes & survival vs matched external controls after long-term treatment (>5yrs.) …
Corcept Therapeutics Reports the US FDA Approval of Lifyorli (Relacorilant) to Treat Platinum-Resistant Ovarian Cancer
Shots: The US FDA has approved Lifyorli (relacorilant) + nab-paclitaxel for the treatment of adults with epithelial ovarian, fallopian tube, or primary peritoneal cancer who have received 1-3 prior systemic therapies, ≥1 of which included Avastin NDA was supported by P-III (ROSELLA) assessing Lifyorli + nab-paclitaxel vs nab-paclitaxel alone in the above-mentioned pts (n=381) with no…
Merck to Acquire Terns Pharmaceuticals for ~$6.7B
Shots: Merck has entered into a definitive agreement to acquire Terns, incl. its asset TERN-701 asset, expanding its oncology pipeline As per the deal, Merck will acquire Terns for $53/share in cash, representing a total equity value of ~$6.7B (~$5.7B net of acquired cash); closing is expected in Q2’26 TERN-701 is being evaluated in the…