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Daiichi Sankyo grabs first approval for blood cancer drug Ezharmia

pharmaphorum

It is usually treated with chemotherapy, but has a high rate of relapse and a low five-year survival rate of between 12% and 14%. ATL is a rare and highly aggressive form of non-Hodgkin lymphoma (NHL), generally associated with infection by the HTLV-1 retrovirus, that can manifest as either a lymphoma or a leukaemia.

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J&J’s Darzalex Faspro is first US therapy for rare blood disorder

pharmaphorum

Johnson & Johnson’s Darzalex Faspro has become the first product approved by the FDA to treat light chain (AL) amyloidosis, a rare and often fatal blood cell disorder. Until now people with AL amyloidosis have had to rely on chemotherapy, with its accompanying side effects, and other drugs to tackle organ failure once damage gets severe.

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Transforming oncology with antibody therapeutics

European Pharmaceutical Review

Amivantamab was the first bispecific monoclonal antibody (BsMAb) approved in the EU to treat advanced NSCLC with EGFR exon 20 insertion mutations post chemotherapy. They are not US Food and Drug Administration (FDA)-approved for these patients due to the lack of benefit. 2012; 23(8): 6 – 9. Personalized medicine at FDA.

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J&J decides against Erleada+Zytiga combination prostate cancer filing

pharmaphorum

Zytiga is the older of the two drugs and was used in the active control arm of the ACIS study, which tested the combination of Erleada (apalutamide) and Zytiga (abiraterone) in patients with chemotherapy-naïve metastatic castration-resistant prostate cancer (mCRPC).

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Junshi plans filings after toripalimab hits target in upper throat cancer

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China’s Junshi Biosciences has said it plans filings for a new cancer immunotherapy after its toripalimab outperformed standard chemotherapy in cancer of the upper throat in a phase 3 trial. It has also been granted orphan drug designation by the FDA for mucosal melanoma.

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Top 20 Drugs with US Patent Expiry in 2023 Based on Total Sales Value

PharmaShots

Lupin has earned the US FDA approval for the generic version of Banzel as Rufinamide Oral Suspension. It is the only drug in its class of chemotherapy and is developed from the natural substance found in a sea sponge. The exact mechanism of action is uncertain. Glenmark has also released its generic drug version in the US market.

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International regulation: the importance of quality assurance in drug development

European Pharmaceutical Review

Since the first ADC was approved by the EMA in 2012, they have generated a great deal of interest in the oncology field because of their potential to address many of the challenges of traditional chemotherapy options.