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RSS FeedPosted by Michael Wonder on 02 Feb 2025
Life-saving lung cancer drug added to PBS, slashing price from $10,000 a month to $30 per script
1 February 2025 - Australians diagnosed with a rare form of lung cancer will now have access to a life-saving ...
Posted by Michael Wonder on 02 Feb 2025
Cheaper medicine for lung cancer patients
2 February 2025 - The Australian Government is listing Retevmo (selpercatinib) on the PBS for the first time to treat advanced ...
Posted by Michael Wonder on 31 Jan 2025
Datopotamab deruxtecan recommended for approval in the EU by CHMP for patients with previously treated metastatic HR positive, HER2 negative breast cancer
31 January 2025 - Recommendation based on TROPION-Breast01 results showing Daiichi Sankyo and AstraZeneca’s datopotamab deruxtecan reduced risk of disease ...
Posted by Michael Wonder on 31 Jan 2025
Bristol Myers Squibb receives positive CHMP opinion for Opdivo (nivolumab) plus Yervoy (ipilimumab) as a first-line treatment option for adult patients with unresectable or advanced hepatocellular carcinoma
31 January 2025 - Recommendation based on results of Phase 3 CheckMate-9DW clinical trial demonstrating statistically significant and clinically meaningful ...
Posted by Michael Wonder on 31 Jan 2025
Bristol Myers Squibb receives positive CHMP opinion for CAR T cell therapy Breyanzi for relapsed or refractory follicular lymphoma
31 January 2025 - Recommendation based on the Phase 2 TRANSCEND FL study in which 97.1% of patients responded to Breyanzi, ...
Posted by Michael Wonder on 28 Jan 2025
ImmunityBio announces EMA acceptance of marketing authorisation application for Anktiva for the treatment of patients with BCG unresponsive non-muscle invasive bladder cancer carcinoma in situ
27 January 2025 - Submission is based on the on-going QUILT 3.032 study in which 100 patients with Bacillus Calmette-Guérin (BCG)-unresponsive ...
Posted by Michael Wonder on 28 Jan 2025
Enhertu approved in the US as first HER2 directed therapy for patients with HER2 low or HER2 ultralow metastatic breast cancer following disease progression after one or more endocrine therapies
27 January 2025 - Based on DESTINY-Breast06 phase 3 trial results which showed Enhertu demonstrated superiority versus chemotherapy with a ...
Posted by Michael Wonder on 27 Jan 2025
FDA grants priority review to Merck’s application for Welireg (belzutifan) for the treatment of patients with advanced pheochromocytoma and paraganglioma
27 January 2025 - Acceptance based on objective response rate data from the Phase 2 LITESPARK-015 trial evaluating WELIREG in certain ...
Posted by Michael Wonder on 24 Jan 2025
Clarity receives US FDA fast track designation for Cu 64 SAR-bisPSMA in biochemical recurrence of prostate cancer
24 January 2025 - Clarity Pharmaceuticals is pleased to announce that the US FDA has granted fast track designation for ...
Posted by Michael Wonder on 23 Jan 2025
Medexus announces FDA approval of Grapafex (treosulphan) for injection
22 January 2025 - Medexus will target a commercial launch in 1H CY2025; potential for annual product-level revenue to exceed ...
Posted by Michael Wonder on 22 Jan 2025
Sarclisa approved in the EU as the first anti-CD38 therapy in combination with standard of care VRd to treat transplant-ineligible newly diagnosed multiple myeloma
22 January 2025 - Approval is based on positive results from the IMROZ Phase 3 study, demonstrating Sarclisa in combination with ...
Posted by Michael Wonder on 22 Jan 2025
Abiraterone acetate with niraparib tosylate monohydrate and prednisone for untreated hormone-relapsed metastatic prostate cancer
22 January 2025 - NICE is unable to make a recommendation on the use in the NHS of abiraterone acetate with ...
Posted by Michael Wonder on 22 Jan 2025
Replimune announces biologics license application acceptance and priority review for RP1 for the treatment of advanced melanoma
21 January 2025 - PDUFA action date of 22 July 2025, with priority review. ...
Posted by Michael Wonder on 21 Jan 2025
NICE has made six times more lung cancer treatment recommendations over the past ten years than in the previous decade
21 January 2025 - We have also recommended osimertinib for routine use on the NHS today. ...
Posted by Michael Wonder on 21 Jan 2025
European Commission approves Lazcluze (lazertinib) in combination with Rybrevant (amivantamab) for the first-line treatment of patients with EGFR-mutated advanced non-small cell lung cancer
21 January 2025 - Latest topline data from the Phase 3 MARIPOSA study shows amivantamab plus lazertinib is the first regimen ...