Pharmaceutical Technology

FEBRUARY 5, 2023

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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Pharmaceutical Technology

MARCH 23, 2023

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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Pharmaceutical Technology

NOVEMBER 9, 2022

The US Food and Drug Administration (FDA) has approved Regeneron Pharmaceuticals ’ PD-1 inhibitor Libtayo (cemiplimab-rwlc) and chemotherapy combination as the first-line treatment for advanced non-small cell lung cancer (NSCLC). The regulatory approval is based on results obtained from the international Phase III EMPOWER-Lung 3 trial.

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pharmaphorum

OCTOBER 19, 2020

Combination therapies involving Roche and AbbVie’s cancer drug Venclexta have been formally approved by the FDA in acute myeloid leukaemia, following supportive data from late-stage studies. The post FDA grants full approval for Roche/AbbVie’s Venclexta in AML combination therapies appeared first on. months compared with 4.1

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Pharmaceutical Technology

MAY 22, 2023

The US Food and Drug Administration (FDA) has granted approval to AbbVie and Genmab ‘s Epkinly (epcoritamab-bysp) to treat relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) in adult patients. The FDA approval of Epkinly represents a new treatment mechanism of action for third-line DLBCL patients. “As

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APRIL 14, 2021

Gilead’s Trodelvy has another string to its bow after FDA approval in patients with advanced metastatic urothelial cancer. . Trodelvy (sacituzumab govitecan) has been approved for locally advanced or metastatic urothelial cancer, following a platinum-containing chemotherapy and PD-1/PD-L1 inhibitor immunotherapy.

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APRIL 1, 2021

The FDA has approved Sanofi’s Sarclisa (isatuximab) in combination with a new chemotherapy regimen for advanced multiple myeloma, building on a first approval last year. In the trial, 8% of patients dropped out because of adverse events and 2.8% quit because of an infection.

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