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STAT+: FDA alters warning label for Carvykti CAR-T, although link to secondary cancers is unclear

STAT

The Food and Drug Administration issued a change to the warning label for Legend Biotech and Janssen’s myeloma CAR-T, Carvykti or cilta-cel, adding that some secondary blood cancers have occurred following treatment for multiple myeloma with the cell therapy. 

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AstraZeneca-Daiichi Sankyo’s Enhertu gets US FDA approval for breast cancer

Pharmaceutical Technology

AstraZeneca and Daiichi Sankyo ’s Enhertu (trastuzumab deruxtecan) has received expanded approval from the US Food and Drug Administration (FDA) to treat adults with unresectable or metastatic HER2-low (IHC 1+ or IHC 2+/ISH-) breast cancer. months for the chemotherapy arm. months compared with 5.1 months compared with 16.8

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FDA clears Xalkori for inflammatory myofibroblastic tumours

pharmaphorum

Pfizer’s tyrosine kinase inhibitor Xalkori has picked up a fourth approval from the FDA, adding a new use in the treatment of a rare form of benign tumour that typically affects children and young adults. The post FDA clears Xalkori for inflammatory myofibroblastic tumours appeared first on.

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FDA grants approval to Gilead Sciences’ breast cancer therapy

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has granted approval for Gilead Sciences ’ Trodelvy (sacituzumab govitecan-hziy) to treat unresectable locally advanced or metastatic hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative (IHC 0, IHC 1+ or IHC 2+/ISH–) breast cancer adult patients. Trodelvy showed 3.2

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STAT+: Springworks wins FDA approval for drug to treat desmoid tumors

STAT

There are no currently approved therapies for desmoid tumors, but doctors often treat patients with chemotherapy, off-label targeted therapies, radiation, and surgery. The tumors do not spread to other parts of the body but can cause severe disability and pain in the tissues that they impact, like muscle or nerves.

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AZ, Merck get FDA okay for Lynparza as adjuvant breast cancer therapy

pharmaphorum

The FDA has cleared AstraZeneca and Merck & Co’s Lynparza as an adjuvant or neoadjuvant treatment for breast cancer, extending its lead over pretenders to its PARP inhibitor crown. The post AZ, Merck get FDA okay for Lynparza as adjuvant breast cancer therapy appeared first on.

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US FDA approves Incyte’s merkel cell carcinoma therapy

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has approved Incyte ’s Zynyz (retifanlimab-dlwr) to treat metastatic or recurrent locally advanced merkel cell carcinoma (MCC) in adult patients. Zynyz monotherapy showed a 52% objective response rate (ORR) in chemotherapy-naïve patients.

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