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FDA Approvals, News & Updates

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.
FDA Approved Breyanzi, Novel Gene Therapy, for Large B-Cell Lymphoma
FDA Approvals, News & UpdatesLymphoma
“Today’s approval represents another milestone in the rapidly progressing field of gene therapy,” said Peter Marks, MD, PhD, Director of the FDA’s Center for Biologics Evaluation and Research.
FDA Approved Ukoniq, New Targeted Therapy, for Marginal-Zone and Follicular Lymphoma
FDA Approvals, News & UpdatesFollicular LymphomaLymphoma
Ukoniq is the first dual inhibitor of PI3K-delta and CK1-epsilon to be approved by the FDA, and is the first targeted, once-daily oral therapy option for marginal-zone or follicular lymphoma.
Yescarta First Gene Therapy Approved for Follicular Lymphoma
FDA Approvals, News & UpdatesFollicular Lymphoma
Yescarta is the first CAR T-cell therapy approved by the FDA for patients with follicular lymphoma. It uses the patient’s own genetically modified T-cells to fight the cancer.
FDA Approves Abecma, First CAR T-Cell Therapy for Multiple Myeloma
FDA Approvals, News & UpdatesMultiple Myeloma
Abecma is the first gene therapy approved by the FDA for patients with multiple myeloma. It uses the patient’s own genetically modified T-cells to fight the cancer.
FDA Approved Pepaxto for Relapsed or Refractory Multiple Myeloma
FDA Approvals, News & UpdatesMultiple Myeloma
Pepaxto is a novel therapy that has shown good results in multiple myeloma that does not respond to other therapies, according to myeloma expert Paul G. Richardson, MD, of Dana-Farber Cancer Institute.
Libtayo Approved for Some Patients with Basal-Cell Carcinoma
FDA Approvals, News & UpdatesSkin Cancer
The immunotherapy Libtayo is a new treatment option for advanced or metastatic basal-cell carcinoma, a type of skin cancer. Libtayo was initially approved for a different type of skin cancer.
Libtayo Approved for First-Line Treatment of Advanced Lung Cancer
FDA Approvals, News & UpdatesLung Cancer
The immunotherapy Libtayo received FDA approval as the first treatment option for patients with advanced or metastatic non–small-cell lung cancer and high PD-L1 expression.
FDA Approved Margenza for Patients with Metastatic HER2-Positive Breast Cancer
Breast CancerFDA Approvals, News & Updates
In December 2020, the FDA approved Margenza (margetuximab-cmkb), a new targeted therapy, for the treatment of patients with metastatic HER2-positive breast cancer, representing an important new option for patients with this type of breast cancer that continues to progress despite different treatments.
FDA Approves Tepmetko, New Targeted Therapy, for Patients with Metastatic Lung Cancer and MET Exon 14 Alterations
Lung CancerFDA Approvals, News & Updates
In February 2021, the FDA approved Tepmetko (tepotinib), a new oral targeted therapy, for the treatment of all adults with metastatic non–small-cell lung cancer and MET exon 14 alterations. Tepmetko is the second MET inhibitor that has been approved by the FDA.
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