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FDA Approvals, News & Updates

Sarclisa Now Approved for Relapsed or Refractory Multiple Myeloma
FDA Approvals, News & UpdatesMultiple Myeloma
In March 2021, the FDA approved a new indication for Sarclisa (isatuximab-irfc), in combination with Kyprolis and dexamethasone, for the treatment of adults with relapsed or refractory multiple myeloma.
Zynlonta First FDA-Approved CD19-Targeted Therapy for Large B-Cell Lymphoma
FDA Approvals, News & UpdatesLymphoma
In April 2021, the FDA approved Zynlonta (loncastuximab tesirine), the first CD19-directed antibody–drug conjugate, for the treatment of patients with relapsed or refractory large B-cell lymphoma.
Lumakras First FDA-Approved Drug for Advanced Lung Cancer and KRAS G12C Mutation
FDA Approvals, News & UpdatesLung Cancer
In May 2021, the FDA approved Lumakras (sotorasib), an oral KRAS inhibitor, for the treatment of adults with locally advanced or metastatic non–small-cell lung cancer associated with KRAS G12C mutation. Lumakras is the first drug approved for any cancer associated with any KRAS mutation.
Rybrevant First FDA-Approved Therapy for Lung Cancer with EGFR Exon 20 Insertion Mutations
FDA Approvals, News & UpdatesLung Cancer
In May 2021, the FDA approved Rybrevant (amivantamab-vmjw), an intravenous antibody that targets mutations in the EGFR and MET pathways, for the treatment of adults with non–small-cell lung cancer and EGFR exon 20 insertion mutations. This is the first drug approved for lung cancer with EGFR exon 20 insertion mutations.
Lorbrena Approved for First-Line Treatment of Metastatic Lung Cancer with ALK Mutation
FDA Approvals, News & UpdatesLung Cancer
In March 2021, the FDA approved Lorbrena (lorlatinib), a third-generation ALK inhibitor, for first-line treatment of patients with non–small-cell lung cancer and ALK mutation. Lorbrena was previously approved for the second- or third-line treatment for this patient population.
Cosela First CDK4/6 Inhibitor FDA Approved to Reduce Myelosuppression in Small-Cell Lung Cancer
FDA Approvals, News & UpdatesLung Cancer
In February 2021, the FDA approved Cosela (trilaciclib) as the first CDK4/6 inhibitor to reduce the risk of chemotherapy-induced myelosuppression in adults with extensive-stage small-cell lung cancer. Cosela can prevent damage to bone marrow cells by blocking the CDK4/6 enzyme.
Drug Watch: Recently FDA-Approved Breast Cancer Treatments
Breast CancerFDA Approvals, News & Updates
There are more treatment options available for breast cancer than ever before – and more are coming. Here’s an overview of the most recently approved medicines.
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