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BMS Receives EC Approval for CAR T Cell Therapy Breyanzi for Relapsed or Refractory Large B-cell Lymphoma After One Prior Therapy

LifeProNow

The standard therapy for these patients consists of intensive salvage immunochemotherapy followed by high-dose chemotherapy and HSCT for those whose disease responds to the salvage therapy and are eligible for transplant. Any-grade neurologic events were reported in 10.9% Median PFS was not reached (95% CI: 12.6-NR) months (95% CI: 4.3-8.6)

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Sanofi’s Sarclisa gains new US multiple myeloma indication

pharmaphorum

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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XTANDI® plus Leuprolide Reduced the Risk of Metastasis by 58% in Non-Metastatic Hormone-Sensitive Prostate Cancer versus Placebo plus Leuprolide

LifeProNow

The most common adverse events in those treated with XTANDI plus leuprolide were fatigue, hot flush, and arthralgia and in those treated with XTANDI monotherapy were fatigue, gynecomastia, and arthralgia. Grade 3-4 ischemic events occurred in 1.4% events led to death in 0.4% of patients on XTANDI versus 0.7% on placebo.

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FDA slaps hold on trials of Gilead’s CD47 drug magrolimab

pharmaphorum

The regulatory move applies only to trials of magrolimab given alongside Bristol-Myers Squibb’s Vidaza (azacitidine), and stems from an “imbalance” in investigator-reported serious adverse events between study arms, said the drugmaker.

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EC approves Libtayo® for metastatic cervical cancer

European Pharmaceutical Review

s Libtayo ® (cemiplimab) for adults with recurrent or metastatic cervical cancer and disease progression while on or after platinum-based chemotherapy. “Libtayo ® was the first programmed cell death protein (PD)-1 inhibitor to demonstrate significant improvements in survival compared to chemotherapy in a Phase III trial.

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Fluoride And Your Thyroid

The Thyroid Pharmacist

They include anesthetics, antacids, anti-anxiety medications, antibiotics, antidepressants, antifungals, cholesterol-lowering medications, anti-malarial medications, chemotherapy, appetite suppressants, arthritis medications, psychotropics, and steroids. Who is Likely to Have an Adverse Reaction to Fluoride, and What are the Symptoms?

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BMS Submits Application for Abecma® for Relapsed or Refractory Multiple Myeloma

LifeProNow

Monitor for neurologic events after treatment with ABECMA. Hemophagocytic Lymphohistiocytosis/Macrophage Activation Syndrome (HLH/MAS) including fatal and life-threatening reactions, occurred in patients following treatment with ABECMA. Provide supportive care and/or corticosteroids as needed. Three cases of Grade 2 HLH/MAS resolved.