Blog
RSS FeedPosted by Michael Wonder on 19 Sep 2021
Merck receives positive EU CHMP opinion for Keytruda (pembrolizumab) in combination with chemotherapy for certain patients with locally recurrent unresectable or metastatic triple negative breast cancer whose tumours express PD-L1 (CPS ≥10)
17 September 2021 - Recommendation based on data from Phase 3 KEYNOTE-355 trial. ...
Posted by Michael Wonder on 19 Sep 2021
BeiGene receives positive CHMP opinion for Brukinsa (zanubrutinib) for the treatment of adults with Waldenström’s macroglobulinaemia
17 September 2021 - The CHMP recommendation is based on results from the Phase 3 ASPEN trial, in which BRUKINSA ...
Posted by Michael Wonder on 18 Sep 2021
Roche receives positive CHMP opinion for Gavreto (pralsetinib) for the treatment of adults with RET fusion positive advanced non-small-cell lung cancer
17 September 2021 - If approved, Gavreto will be the first and only targeted treatment approved by the EMA that ...
Posted by Michael Wonder on 18 Sep 2021
Incyte announces Health Canada conditional approval of Pemazyre (pemigatinib) as first targeted treatment for adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma
17 September 2021 - Incyte today announced that Health Canada has granted a Notice of Compliance with conditions for Pemazyre (pemigatinib), ...
Posted by Michael Wonder on 18 Sep 2021
Exelixis announces U.S. FDA approval of Cabometyx (cabozantinib) for patients with previously treated radioactive iodine-refractory differentiated thyroid cancer
17 September 2021 - FDA approval based on Phase 3 COSMIC-311 pivotal trial, which demonstrated significant improvement in progression-free survival with ...
Posted by Michael Wonder on 17 Sep 2021
Keytruda made available on the NHS for certain oesophageal cancer patients
17 September 2021 - NICE has recommended MSD’s Keytruda (pembrolizumab) combined with chemotherapy for the first-line treatment of certain oesophageal ...
Posted by Michael Wonder on 16 Sep 2021
Nivolumab in skin cancer: additional benefit upgraded on the basis of an indirect comparison
16 September 2021 - For nivolumab (Opdivo), the pharmaceutical company was able to achieve a significantly better result in a second ...
Posted by Michael Wonder on 16 Sep 2021
Takeda’s Exkivity (mobocertinib) approved by U.S. FDA as the first oral therapy specifically designed for patients with EGFR exon 20 insertion positive NSCLC
15 September 2021 - Next generation sequencing companion diagnostic test approved simultaneously to support identification of patients with EGFR exon 20 ...
Posted by Michael Wonder on 15 Sep 2021
Venetoclax in acute myeloid leukaemia: indication of a considerable added benefit
15 September 2021 - Third new area of application/those affected still live a good year on average - and thus ...
Posted by Michael Wonder on 15 Sep 2021
U.S. FDA grants Brukinsa (zanubrutinib) accelerated approval in relapsed or refractory marginal zone lymphoma
15 September 2021 - This marks the third FDA approval for Brukinsa and first approval in marginal zone lymphoma. ...
Posted by Michael Wonder on 15 Sep 2021
NICE backs Opdivo for head and neck cancer
15 September 2021 - NICE has recommended Bristol Myers Squibb’s (BMS) immunotherapy Opdivo (nivolumab) for routine use on the NHS ...
Posted by Michael Wonder on 15 Sep 2021
Health Canada approves Lumakras (sotorasib), the first and only targeted treatment for patients with KRAS G12C mutated locally advanced or metastatic non--small cell lung cancer
14 September 2021 - Once daily dosing option now available to address KRAS G12C, a driver of tumour growth found ...
Posted by Michael Wonder on 14 Sep 2021
Drug prices and value of oncology drugs in Italy
13 September 2021 - The main objective of this study was to evaluate the potential role of efficacy data and other ...
Posted by Michael Wonder on 14 Sep 2021
Trodelvy approved by the TGA
14 September 2021 - Sacituzumab govitecan is a new treatment option for adult patients with unresectable locally advanced or metastatic triple negative ...
Posted by Michael Wonder on 14 Sep 2021
ISA Pharmaceuticals receives fast track designation for lead product ISA101b
14 September 2021 - Fast track designation for the treatment of recurrent and metastatic HPV16 positive oropharyngeal cancer to improve ...