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RSS FeedPosted by Michael Wonder on 06 Feb 2025
FDA approves treosulfan with fludarabine as a preparative regimen for alloHSCT in adult and paediatric patients with AML or MDS
21 January 2025 - Today, the FDA approved treosulfan (Grafapex, medac), an alkylating agent, with fludarabine as a preparative regimen ...
Posted by Michael Wonder on 06 Feb 2025
Serplulimab approved in the EU for first-line treatment of extensive-stage small cell lung cancer
5 February 2025 - Serplulimab is the world's first anti-PD-1 monoclonal antibody approved for first-line treatment of extensive stage small-cell lung ...
Posted by Michael Wonder on 05 Feb 2025
Pembrolizumab for adjuvant treatment of patients with resected non-small-cell lung cancer (final guidance)
5 February 2025 - NICE has published final evidence-based recommendations on the use of pembrolizumab (Keytruda) for the adjuvant treatment ...
Posted by Michael Wonder on 05 Feb 2025
Elacestrant dihydrochloride for the treatment of patients with advanced, oestrogen receptor positive, HER2 negative breast cancer with an ESR1 mutation after endocrine treatment (final guidance)
5 February 2025 - Evidence-based recommendations on elacestrant (Korserdu) for treating oestrogen receptor-positive HER2-negative advanced breast cancer with an ESR1 mutation ...
Posted by Michael Wonder on 04 Feb 2025
CHMP recommends subcutaneous Rybrevant (amivantamab) for the treatment of patients with advanced EGFR mutated non-small cell lung cancer
3 February 2025 - Data from the Phase 3 PALOMA-3 study showed non-inferiority to intravenous administration meeting both co-primary pharmacokinetic endpoints, ...
Posted by Michael Wonder on 04 Feb 2025
Durvalumab with tremelimumab for the first-line treatment of patients with advanced or unresectable hepatocellular carcinoma
4 February 2025 - The Department of Health and Social Care has asked NICE to produce guidance on the use ...
Posted by Michael Wonder on 04 Feb 2025
Insurer denies access to drugs granted accelerated approval by FDA
3 January 2025 - An insurer’s decision to delay reimbursement of drugs licensed under the FDA’s accelerated approval program has sparked ...
Posted by Michael Wonder on 03 Feb 2025
Imfinzi recommended for approval in the EU by CHMP as first and only immunotherapy for limited-stage small cell lung cancer
3 February 2025 - Recommendation based on ADRIATIC Phase 3 trial results which showed a 27% reduction in the risk ...
Posted by Michael Wonder on 03 Feb 2025
Roche receives FDA approval for the first companion diagnostic to identify patients with HER2 ultralow metastatic breast cancer eligible for Enhertu
31 January 2025 - The PATHWAY HER2 (4B5) test, the first and only FDA approved companion diagnostic for assessing HER2 low ...
Posted 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 ...