Remove 2017 Remove Chemotherapy Remove Labelling
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New Frontline BTK Inhibitor Strategy Gains FDA Approval in Untreated Mantle Cell Lymphoma

Pharmacy Times

Acalabrutinib had previously received approval in 2017 as a single agent for this same indication. Because of its aggressive nature, MCL is typically treated with combination chemotherapy at diagnosis. The recent application was granted both priority review and orphan drug designation.

FDA
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NICE says no to AZ’s Lynparza for prostate cancer

pharmaphorum

AZ is seeking to use Lynparza in patients who had also been previously treated with the chemotherapy drug docetaxel, but NICE has concluded that the application failed to provide evidence of the PARP inhibitor’s value compared to standard therapy.

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BMS finally gets FDA OK for liso-cel, sets $410k launch price

pharmaphorum

Breyanzi has however been cleared with a similar black box warning on its label for neurotoxicity and cytokine release syndrome (CRS) as Novartis and Gilead/Kite’s therapies. At the moment there are limited fallback options for patients whose lymphoma progresses despite first line chemotherapy and anti-CD20 treatment.

FDA
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Targeting tumours with novel radiopharmaceuticals

European Pharmaceutical Review

How do you perceive radiopharmaceuticals complementing existing cancer treatments, such as chemotherapy and immunotherapy? There is great hope of this class of drug specifically to work in conjunction with immunotherapeutics, given the lack of toxicity of radiopharmaceuticals in general compared to most chemotherapies. cited 2023Oct].

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Keytruda should lose stomach cancer indication, says ODAC

pharmaphorum

Merck’s drug has been approved for this use since 2017, but failed to show a statistically significant improvement over third-line chemotherapy in either of two confirmatory trials – KEYNOTE-061 and KEYNOTE-062.

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Novartis’ bid to extend Kymriah into earlier use hits a roadblock

pharmaphorum

Novartis’ CAR-T therapy Kymriah racked up back-to-back approvals in acute lymphoblastic leukaemia and large B-cell lymphoma a few years ago, but hasn’t added to its label since. Standard care was salvage chemotherapy followed in eligible patients by high-dose chemotherapy and a stem cell transplant.

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SPuMoNI: Enhancing Pharma Data Quality through Smart Technologies

ISPE

Mexican Governor: Cancer Children Given Water Instead of Chemotherapy.” Published 19 January 2017. Presented at the 2017 IFIP/IEEE Symposium on Integrated Network and Service Management (IM), Lisbon, Portugal, 8–12 May 2017: 772–77. 30 June 2016. link] 6 BBC News. link] 7 He, J., Cai, and X. doi: 10.1109/TSP.2020.3006760