FDA Approvals, News & Updates

Keytruda plus Lenvima Combo FDA Approved for Advanced Endometrial Carcinoma with No MSI-H or dMMR Tumors

October 2019, Vol 10, No 5 - FDA Approvals, News & Updates

On September 17, 2019, the FDA accelerated the approval of a new combination of pembrolizumab (Keytruda; Merck) plus lenvatinib (Lenvima; Eisai) for patients with advanced endometrial carcinoma that is not associated with microsatellite instability high (MSI-H) or mismatch repair–deficient (dMMR) tumors in patients whose disease progressed after systemic therapy and who are candidates for curative surgery or radiation. The FDA granted this application priority review and a breakthrough therapy designation. [ Read More ]

FDA Approved Erleada for Metastatic Castration-Sensitive Prostate Cancer

October 2019, Vol 10, No 5 - FDA Approvals, News & Updates

On September 17, 2019, the FDA approved a new indication for apalu­tamide (Erleada; Janssen Biotech) for the treatment of patients with metastatic castration-sensitive prostate cancer (CSPC). Apalutamide was initially approved in 2018 for the treatment of nonmetastatic castration-resistant prostate cancer. The FDA granted apalutamide priority review for the new indication. [ Read More ]

Inrebic Receives FDA Approval for Adults with Myelofibrosis

October 2019, Vol 10, No 5 - FDA Approvals, News & Updates

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. [ Read More ]

Turalio First FDA-Approved Systemic Therapy for Tenosynovial Giant-Cell Tumor

October 2019, Vol 10, No 5 - FDA Approvals, News & Updates

On August 2, 2019, the FDA approved pexidartinib (Turalio; Daiichi Sankyo) capsules, a kinase inhibitor, for adults with symptomatic tenosynovial giant-cell tumor (TGCT), which is associated with severe morbidity or functional limitations, who are not candidates for surgery. Pexidartinib is the first systemic therapy approved for patients with TGCT. The FDA granted pexidartinib a priority review and breakthrough therapy and orphan drug designations. [ Read More ]

Rozlytrek Third FDA-Approved Tumor-Agnostic Drug and Second Treatment for Patients with NTRK Fusion Tumors

October 2019, Vol 10, No 5 - FDA Approvals, News & Updates

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. [ Read More ]

Nubeqa New Oral Therapy FDA Approved for Nonmetastatic Prostate Cancer

October 2019, Vol 10, No 5 - FDA Approvals, News & Updates

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. [ Read More ]

FDA Approves Darzalex Combination for First-Line Treatment of Transplant-Eligible Patients with Multiple Myeloma

FDA Approvals, News & Updates, In the News, Multiple Myeloma

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. [ Read More ]

Darzalex Combined with Revlimid and Dexamethasone New First-Line Regimen for Patients with Multiple Myeloma Ineligible for Transplant

August 2019, Vol 10, No 4 | Payers’ Perspectives In Oncology: ASCO 2019 Highlights - FDA Approvals, News & Updates, Multiple Myeloma

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. [ Read More ]

Keytruda Receives New Indication for Metastatic Small-Cell Lung Cancer After Disease Progression

August 2019, Vol 10, No 4 | Payers’ Perspectives In Oncology: ASCO 2019 Highlights - FDA Approvals, News & Updates, Lung Cancer

On June 17, 2019, the FDA granted accelerated approval to pembrolizumab (Keytruda; Merck) monotherapy for the treatment of patients with metastatic small-cell lung cancer whose disease progressed during or after platinum-­based chemotherapy and at least 1 previous therapy. The FDA granted this application a priority review, making it the fifth FDA approval this year for pembrolizumab. [ Read More ]

Keytruda First PD-1 Inhibitor Approved as First-Line Monotherapy for Patients with Metastatic or Unresectable Head and Neck Cancer

August 2019, Vol 10, No 4 | Payers’ Perspectives In Oncology: ASCO 2019 Highlights - FDA Approvals, News & Updates, Head and Neck Cancer

On June 10, 2019, the FDA approved pembrolizumab (Keytruda; Merck) as monotherapy or in combination with platinum and fluorouracil for the treatment of newly diagnosed patients with metastatic or unresectable recurrent head and neck squamous-cell carcinoma (HNSCC) whose tumors express PD-L1 (combined positive score [CPS] ≥1), as determined by an FDA-­approved test. The FDA reviewed the application for this new indication under its priority review program. [ Read More ]