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FDA Approvals

FDA Approvals

FDA Clears Application for Anti-PD-1 CAR-T to Treat Hematologic, Breast Cancers

The FDA clears investigational new drug application for PRGN-3007, a chimeric antigen receptor T-cell therapy for patients with advanced hematologic malignancies or solid tumors expressing ROR1.

Healio
10/26/2021
Keytruda Approved as First-Line Treatment for Persistent, Recurrent or Metastatic Cervical Cancer

The FDA approves keytruda in combination with chemotherapy, with or without bevacizumab, for patients with persistent, recurrent, or metastatic cervical cancer whose tumors express PD-L1...

Cancer Therapy Advisor
10/14/2021
FDA Approves Tecentriq for New Lung Cancer Indication

The FDA expanded the approval of atezolizumab to include adjuvant treatment of certain patients with NSCLC. 

Healio
10/15/2021

FDA Approves Pembrolizumab Plus Chemo as First-Line Therapy for Advanced, Recurrent Cervical Cancer

The FDA has approved the checkpoint inhibitor pembrolizumab alongside standard chemotherapy, as first-line therapy for patients with PD-L1-expressing cervical cancer.

Medscape
10/13/2021
FDA Approves Verzenio for Certain Patients With Early Breast Cancer

The approval applies to use of the agent by adults with hormone receptor-positive, HER2-negative, node-positive disease at high risk for recurrence who have a Ki-67 score of at least 20%.

Healio
10/13/2021
FDA Grants Breakthrough Device Designation to Alpha DaRT for Glioblastoma

Alpha DaRT is proposed as an adjunct to standard medical therapies for patients with glioblastoma multiforme or as standalone therapy for patients who have exhausted standard therapies.

Healio
10/08/2021
FDA Approves Brexucabtagene Autoleucel for Relapsed or Refractory B-Cell Precursor ALL

The FDA approves brexucabtagene autoleucel, a CD19-directed CAR T-cell therapy, for adult patients with relapsed or refractory B-cell precursor ALL.

The ASCO Post
10/04/2021
FDA Approves Erbitux With Braftovi for Colorectal Cancer Subset

The FDA approval is based on results of the randomized phase 3 BEACON CRC trial, which included patients with BRAF V600E-mutant mCRC that progressed after one or two prior regimens.

Healio
09/29/2021
FDA Grants Orphan Drug Designation to Nadunolimab for Pancreatic Cancer

Nadunolimab (CAN04, Cantargia AB) is an IL1RAP-binding antibody in development for various types of cancer including pancreatic ductal adenocarcinoma.  

Healio
09/27/2021
FDA Approves Cabozantinib for Differentiated Thyroid Cancer

The FDA approves Cabozantinib, indicated for patients whose disease has progressed after they have received VEGFR-targeted therapy...

Medscape
09/22/2021
FDA Grants Fast Track Designation to CAR Macrophage Cell Therapy for HER2-Positive Tumors

The FDA granted fast track designation to CT-0508 for treatment of patients with solid tumors that overexpress human epidermal growth factor receptor 2.

Healio
09/22/2021
FDA Clears IND Application For CRISPR-Edited T-Cell Receptor Therapy to Treat AML

The FDA cleared an investigational new drug application for NTLA-5001, a T-cell receptor T-cell therapy designed to treat adults with relapsed or refractory acute myeloid leukemia.

Healio
09/17/2021
FDA Approves Tivdak for Advanced Cervical Cancer

The FDA granted accelerated approval to tisotumab vedotin-tftv for certain women with advanced cervical cancer.

Healio
09/21/2021
FDA Approves Cabozantinib for Patients With Previously Treated Radioactive Iodine–Refractory Differentiated Thyroid Cancer

The FDA approves cabozantinib for the treatment of adult and pediatric patients aged 12 years and older with locally advanced or metastatic differentiated thyroid cancer...

The ASCO Post
09/18/2021
FDA Approves First Oral Drug for NSCLC With EGFR Exon20 Insertion

The FDA grants accelerated approval to mobocertinib for the treatment of patients with locally advanced or metastatic non–small-cell lung cancer with EGFR exon 20 insertion mutations.

Medscape
09/16/2021
FDA Approval for Zanubrutinib in Waldenström’s Macroglobulinemia

The FDA has approved zanubrutinib capsules for use in the treatment of adult patients with Waldenström's macroglobulinemia.

Medscape
09/02/2021
FDA Grants Fast Track Designation to IN10018 For Ovarian Cancer

Preclinical and clinical data suggests the agent has promising efficacy when combined with standard chemotherapy for women with platinum-resistant ovarian cancer.

Healio
08/21/2021
FDA Grants Accelerated Approval to Dostarlimab-gxly for dMMR Advanced Solid Tumors

The FDA granted accelerated approval to dostarlimab-gxly for adult patients with mismatch repair–deficient recurrent or advanced solid tumors, as determined by an FDA-approved test...

The ASCO Post
08/18/2021
FDA Grants Orphan Drug Designation to Allogeneic CAR-T for Advanced Multiple Myeloma

 

The FDA granted orphan drug designation to ALLO-715 for the treatment of advanced multiple myeloma.

Healio
08/18/2021
FDA Approves Belzutifan for Cancers Associated With von Hippel-Lindau Disease

The FDA approves belzutifan for adult patients with VHL disease who require therapy for associated RCC, CNS hemangioblastomas, or pancreatic neuroendocrine tumors not requiring immediate surgery.

The ASCO Post
08/13/2021
FDA Approves Lenvatinib/Pembrolizumab for Advanced Renal Cell Carcinoma

The FDA approves the combination of lenvatinib plus pembrolizumab for the first-line treatment of adult patients with advanced renal cell carcinoma.

The ASCO Post
08/12/2021
FDA Approves Pembrolizumab in Combination for High-Risk, Early-Stage TNBC

The FDA approves pembrolizumab for high-risk, early-stage TNBC in combination with CT as a neoadjuvant treatment, and then continued as a single agent as adjuvant treatment after surgery.

The ASCO Post
07/27/2021
FDA Grants Regular Approval to Pembrolizumab/Lenvatinib for Advanced Endometrial Carcinoma

The FDA approves pembrolizumab in combination with lenvatinib for patients with advanced endometrial carcinoma that is not MSI-H or dMMR who have disease progression following...

The ASCO Post
07/22/2021
FDA Approves Belumosudil for Chronic Graft-vs-Host Disease

The FDA approves belumosudil for adult and pediatric patients aged 12 years and older with chronic GvHD after failure of at least two prior lines of systemic therapy.

The ASCO Post
07/19/2021
FDA Grants Regular Approval to Enfortumab Vedotin-ejfv for Locally Advanced or Metastatic Urothelial Cancer

The FDA approved enfortumab vedotin-ejfv for adult patients with locally advanced or metastatic urothelial cancer who have previously received a PD-1 or PD-L1 inhibitor and platinum-containing CT..

The ASCO Post
07/09/2021
FDA Approves Expanded Indication for Pembrolizumab in Locally Advanced Cutaneous Squamous Cell Carcinoma

The FDA approves an expanded label for pembrolizumab, an anti–PD-1 agent, as monotherapy for patients with locally advanced cSCC that is not curable by surgery or radiation.

The ASCO Post
07/06/2021
FDA Approves New Asparaginase Product for Leukemia

The FDA has approved a new version of asparaginase for use in children and adults who have developed hypersensitivity to asparaginase derived from Escherichia coli.

Medscape
07/02/2021
FDA Approves Avapritinib for Advanced Systemic Mastocytosis

The FDA approves the tyrosine kinase inhibitor avapritinib for adult patients with advanced systemic mastocytosis, including patients with aggressive systemic mastocytosis, systemic mastocytosis...

The ASCO Post
06/17/2021
FDA Approves New Pediatric Indication for Technetium Tc 99m Tilmanocept Injection

The Lymphoseek injection—a radiopharmaceutical agent specifically designed for targeted lymphatic mapping and guiding sentinel lymph node biopsies—has been approved for pediatric use by the FDA.

The ASCO Post
06/11/2021
FDA OKs First Targeted Therapy for Subset of Patients With NSCLC

The FDA approves amivantamab as the first targeted treatment for patients with NSCLC harboring epidermal growth factor receptor exon 20 insertion mutations.

Medscape
05/21/2021
FDA Grants Accelerated Approval to Amivantamab-vmjw for Metastatic EGFR Exon 20 Insertion–Mutated NSCLC

The FDA approves amivantamab-vmjw for adult patients with locally advanced or metastatic NSCLC and EGFR exon 20 insertion mutations, as detected by an FDA-approved test, whose disease...

The ASCO Post
05/21/2021
FDA OKs Nivolumab After Surgery for Esophageal or GEJ Cancer

The FDA approves the adjuvant use of nivolumab in patients with resected esophageal or GEJ cancer who have received neoadjuvant CRT and have residual pathological disease following surgery.

Medscape
05/20/2021
FDA Grants Accelerated Approval to Pembrolizumab Combination for HER2-Positive Gastric Cancer

The FDA approves pembrolizumab in combination with trastuzumab plus fluoropyrimidine- and platinum-containing CT for the first-line treatment of patients with locally advanced unresectable or metas

The ASCO Post
05/05/2021

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