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FDA Approvals, News & Updates
FDA Approvals, News & Updates
Inrebic Receives FDA Approval for Adults with Myelofibrosis
FDA Approvals, News & Updates
October 2019, Vol 10, No 5
On August 16, 2019, the FDA approved fedratinib (Inrebic; Celgene/Impact Biomedicines), an oral kinase inhibitor, for adults with intermediate-2 or high-risk primary or secondary—post–polycythemia vera (PV) or post–essential thrombocythemia (ET)—myelofibrosis, a rare bone marrow disorder. The FDA granted fedratinib priority review and an orphan drug designation.
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Rozlytrek Third FDA-Approved Tumor-Agnostic Drug and Second Treatment for Patients with NTRK Fusion Tumors
FDA Approvals, News & Updates
October 2019, Vol 10, No 5
On August 15, 2019, the FDA accelerated the approval of entrectinib (Rozlytrek; Genentech), an oral kinase inhibitor, for the treatment of adults and adolescents whose cancer involves neurotrophic tyrosine receptor kinase (
NTRK
) gene fusion that has no effective treatments. The FDA granted entrectinib a priority review and breakthrough therapy and orphan drug designations. This is the third cancer drug approved by the FDA based on a common biomarker and the second drug for patients with
NTRK
gene fusion.
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Nubeqa New Oral Therapy FDA Approved for Nonmetastatic Prostate Cancer
FDA Approvals, News & Updates
October 2019, Vol 10, No 5
On July 30, 2019, the FDA approved darolutamide (Nubeqa; Bayer HealthCare), an oral androgen receptor inhibitor, for the treatment of patients with nonmetastatic castration-resistant prostate cancer (CRPC). This approval was based on a multicenter, double-blind, placebo-controlled clinical trial known as ARAMIS. The FDA granted this application priority review.
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FDA Approves Darzalex Combination for First-Line Treatment of Transplant-Eligible Patients with Multiple Myeloma
FDA Approvals, News & Updates
,
Hematologic Malignancies
,
In the News
,
Multiple Myeloma
,
Personalized Medicine
Web Exclusives
On September 26, 2019, the FDA approved daratumumab (Darzalex; Janssen) in combination with bortezomib, thalidomide, and dexamethasone for the treatment of newly diagnosed patients with multiple myeloma who are eligible for autologous stem-cell transplant (ASCT). The FDA granted this application priority review.
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Darzalex Combined with Revlimid and Dexamethasone New First-Line Regimen for Patients with Multiple Myeloma Ineligible for Transplant
FDA Approvals, News & Updates
,
Hematologic Malignancies
,
Multiple Myeloma
,
Personalized Medicine
August 2019, Vol 10, No 4 | Payers’ Perspectives In Oncology: ASCO
On June 27, 2019, the FDA approved daratumumab (Darzalex; Janssen) in combination with lenalidomide (Revlimid; Celgene) and dexamethasone for the first-line treatment of patients with multiple myeloma who are ineligible for autologous stem-cell transplantation (ASCT). This approval was granted a priority review and used the Oncology Center of Excellence Real-Time Oncology Review program. This is the sixth indication for daratumumab in multiple myeloma and the second indication for newly diagnosed patients.
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Xpovio Receives FDA Approval for Patients with Relapsed or Refractory Multiple Myeloma
FDA Approvals, News & Updates
,
Hematologic Malignancies
,
Multiple Myeloma
,
Personalized Medicine
August 2019, Vol 10, No 4 | Payers’ Perspectives In Oncology: ASCO
On July 3, 2019, the FDA granted accelerated approval to selinexor (Xpovio; Karyopharm Therapeutics), a nuclear export inhibitor, in combination with dexamethasone, for the treatment of patients with relapsed or refractory multiple myeloma who have received ≥4 previous therapies and did not respond to other forms of treatment, including ≥2 proteasome inhibitors, ≥2 immunomodulatory agents, and an anti-CD38 monoclonal antibody. The FDA reviewed selinexor using its fast track program, and granted it an orphan drug designation.
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Polivy FDA Approved for Patients with Relapsed or Refractory DLBCL
FDA Approvals, News & Updates
,
Lymphoma
August 2019, Vol 10, No 4 | Payers’ Perspectives In Oncology: ASCO
On June 10, 2019, the FDA granted accelerated approval to polatuzumab vedotin-piiq (Polivy; Genentech), a CD79b-directed antibody–drug conjugate, in combination with bendamustine (Bendeka, Treanda) plus rituximab (Rituxan or a biosimilar), for the treatment of patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who have received ≥2 lines of therapy. The FDA granted polatuzumab breakthrough therapy and orphan drug designations.
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Revlimid Approved for Patients with Follicular Lymphoma or Marginal-Zone Lymphoma
FDA Approvals, News & Updates
,
Lymphoma
August 2019, Vol 10, No 4 | Payers’ Perspectives In Oncology: ASCO
On May 28, 2019, the FDA approved lenalidomide (Revlimid; Celgene), in combination with rituximab (Rituxan), for the treatment of patients with previously treated follicular lymphoma or marginal-zone lymphoma (MZL). The FDA used its priority review program for this approval, and granted lenalidomide plus rituximab an orphan drug designation for this new indication.
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Verzenio Receives New Indication as Initial Treatment for Metastatic Breast Cancer
FDA Approvals, News & Updates
Web Exclusives
On February 26, 2018, the FDA approved a new indication for abemaciclib (Verzenio; Eli Lilly), a CDK4/CDK6 inhibitor, alone or in combination with an aromatase inhibitor as initial endocrine-based therapy in postmenopausal women with hormone receptor (HR)-positive, HER2-negative advanced or metastatic breast cancer.
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Keytruda Approved for Patients with Previously Treated Metastatic Small-Cell Lung Cancer
By
Yvette Florio Lane
FDA Approvals, News & Updates
,
In the News
Web Exclusives
Lung cancer is the second most frequently diagnosed malignancy in both men and women (following prostate and breast cancer, respectively), and the leading cause of cancer deaths overall. Non–small-cell lung cancer (NSCLC) is the most common type, with the more aggressive small-cell lung cancer (SCLC) making up approximately 10% to 15% of cases.
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