Expanding Later-Line Treatment Options for Multiple Myeloma: Paul G. Richardson, MD

Earlier this month, ​the FDA approved isatuximab-irfc (Sarclisa​®​, Sanofi), an anti-CD38 monoclonal antibody, in combination with pomalidomide and dexamethasone for adults with multiple myeloma who have received at least two prior lines of treatment, including lenalidomide and a proteasome inhibitor. In this interview with i3 Health, Paul G. Richardson, MD, who served as the co-primary investigator of the ICARIA-MM study, on which the isatuximab approval was based, shares his thoughts on the si...
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Nivolumab/Ipilimumab Approved for Hepatocellular Carcinoma

​The FDA has granted accelerated approval to the combination of nivolumab (Opdivo®, Bristol-Myers Squibb) and ipilimumab (Yervoy®, Bristol-Myers Squibb) for the treatment of patients with hepatocellular carcinoma following treatment with sorafenib.Safety and efficacy were evaluated in Cohort 4 of the phase 1/2 CHECKMATE-040 trial (NCT01658878), in which patients previously treated with sorafenib were randomized to receive either nivolumab 1 mg/kg plus ipilimumab 3 mg/kg every three weeks for fou...
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Neratinib: Progress for HER2-Positive Metastatic Breast Cancer With Adam Brufsky, MD, PhD, FACP

Last week, the FDA added a second approval for neratinib (Nerlynx​®​, Puma Biotechnology, Inc.) in combination with capecitabine for adults with human epidermal growth factor receptor 2 (HER2)-positive advanced breast cancer previously treated with at least two anti-HER2–based regimens in the metastatic setting. This adds to the previous approval of neratinib, an irreversible pan-HER tyrosine kinase inhibitor, for the extended adjuvant treatment of early-stage HER2-positive breast cancer followi...
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Isatuximab Approved for Relapsed/Refractory Multiple Myeloma

​The FDA has now approved isatuximab-irfc (Sarclisa®, Sanofi), an anti-CD38 monoclonal antibody, in combination with pomalidomide and dexamethasone for adults with multiple myeloma who have received at least two prior lines of treatment, including lenalidomide and a proteasome inhibitor."While there is no cure for multiple myeloma, [isatuximab] is now another CD38-directed treatment option added to the list of FDA-approved treatments of patients with multiple myeloma who have progressive disease...
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Neratinib Approved: HER2-Positive Metastatic Breast Cancer

The FDA has approved a supplemental New Drug Application (sNDA) for neratinib (Nerlynx®, Puma Biotechnology, Inc.) in combination with capecitabine for adults with human epidermal growth factor receptor 2 (HER2)-positive advanced or metastatic breast cancer previously treated with at least two anti-HER2–based regimens in the metastatic setting. Neratinib, an irreversible pan-HER tyrosine kinase inhibitor (TKI), has previously been approved for the extended adjuvant treatment of adults with early...
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