In the FDA’s dynamic regulatory environment, the patient voice has been adopted and end points for clinical trials have evolved from overall survival to other efficacy measures. “Having multiple drugs is a good thing. Many are approved on nonsurvival end points, and they have transformed the diseases,” said Richard Pazdur, MD.
On September 1, 2017, the FDA approved gemtuzumab ozogamicin (Mylotarg; Pfizer) for the treatment of adults with newly diagnosed CD33-positive acute myeloid leukemia (AML), as well as patients aged ≥2 years with relapsed or refractory CD33-positive AML. It is approved as an orphan drug for this indication.
On July 31, 2017, the FDA accelerated the approval of a new indication for nivolumab (Opdivo; Bristol-Myers Squibb) for the treatment of patients aged ≥12 years with mismatch repair–deficient (dMMR) and microsatellite instability–high (MSI-H) metastatic colorectal cancer (CRC) that progressed after treatment with fluoropyrimidine, oxaliplatin, and irinotecan.
On August 17, 2017, the FDA approved inotuzumab ozogamicin (Besponsa; Pfizer), a targeted therapy, for the treatment of adults with relapsed or refractory B-cell acute lymphoblastic leukemia (ALL). The drug blocks cancer growth by binding to B-cell ALL cells that express CD22. The FDA designated inotuzumab ozogamicin as an orphan drug and applied its priority review for this approval.
Kymriah First Gene Therapy Approved by the FDA, Indicated for Young Patients with B-Cell ALL and CD19
On August 30, 2017, the FDA approved tisagenlecleucel (Kymriah; Novartis Pharmaceuticals), a genetically modified chimeric antigen receptor (CAR) T-cell immunotherapy, for the treatment of pediatric patients and young adults aged ≤25 years with relapsed or refractory B-cell acute lymphoblastic leukemia (ALL).
- Darzalex Combined with Pomalidomide and Dexamethasone Approved for Relapsed/Refractory Multiple Myeloma
- Rituximab Combination Now Approved in 3 Blood Cancers
- First FDA-Approved Test to Help Detect Several Leukemias and Lymphomas
- DigniCap Cooling System Receives Expanded Indication for Use in Patients with Solid Tumors
- Blincyto Receives Expanded Indication to Include Patients with Ph+ B-Cell Precursor ALL
- First CAR T-Cell Therapy Unanimously Recommended by FDA Advisory Committee for Treatment of B-Cell ALL in Children and Young Adults
- Neratinib First Extended Adjuvant Treatment for Patients with Early-Stage, HER2-Positive Breast Cancer
- Alunbrig, an Oral Kinase Inhibitor, Receives FDA Approval for NSCLC with ALK Mutation
- Rydapt First Drug in Decades Approved by the FDA for Acute Myeloid Leukemia
- Stivarga First Drug in a Decade Approved by the FDA for Liver Cancer
- Atezolizumab Approved as First-Line Treatment for Advanced Bladder Cancer in Some Patients
- Tagrisso Receives Full Approval for NSCLC with EGFR T790M Mutation
- Bavencio, a PD-L1 Inhibitor, First Nonchemotherapy Drug Approved for Merkel-Cell Carcinoma
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Results 41 - 50 of 87
Results 41 - 50 of 87