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Government Shutdown Impacts FDA Drug Approvals
FDA Approvals, News & Updates
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Now in its fourth week, the longest shutdown in the history of the federal government is having an impact on patient care, as the US Food and Drug Administration (FDA) has put drug reviews and approvals for new drugs and devices, as well as the issuance of new guidance documents, on indefinite hold. The FDA recently posted on its website a notice alerting the public of its current operational status.
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Udenyca, Second Biosimilar to Neulasta, FDA-Approved to Reduce Risk for Infection in Patients with Nonmyeloid Malignancies
FDA Approvals, News & Updates
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Biosimilars
December 2018, Vol 9, No 4
On November 2, 2018, the FDA approved pegfilgrastim-cbqv (Udenyca; Coherus BioSciences), as the second biosimilar to pegfilgrastim (Neulasta), to reduce the risk for infection in patients with nonmyeloid malignancies who receive myelosuppressive chemotherapy, which may result in febrile neutropenia.
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Talzenna Approved for HER2-Negative, Locally Advanced Breast Cancer with Germline BRCA Mutations
Breast Cancer
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FDA Approvals, News & Updates
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Solid Tumors
December 2018, Vol 9, No 4
On October 16, 2018, the FDA approved talazoparib (Talzenna; Pfizer), a poly (ADP-ribose) polymerase (PARP) inhibitor, for the treatment of patients with HER2-negative, locally advanced or metastatic breast cancer and deleterious or suspected deleterious germline
BRCA
mutation, as identified by an FDA-approved test.
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Bevacizumab plus Chemotherapy Approved for Several Types of Ovarian Cancer
FDA Approvals, News & Updates
August 2018, Vol 9, No 2 | Payers’ Perspectives In Oncology: ASCO
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Keytruda Receives 2 New Indications: Metastatic Cervical Cancer and Relapsed Mediastinal Large B-Cell Lymphoma
FDA Approvals, News & Updates
August 2018, Vol 9, No 2 | Payers’ Perspectives In Oncology: ASCO
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Venclexta Indicated for CLL or SLL, Alone or in Combination with Rituxan
FDA Approvals, News & Updates
August 2018, Vol 9, No 2 | Payers’ Perspectives In Oncology: ASCO
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Tafinlar-Mekinist Combination Approved for Metastatic Thyroid Cancer with BRAF V600E Mutation
FDA Approvals, News & Updates
August 2018, Vol 9, No 2 | Payers’ Perspectives In Oncology: ASCO
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Kymriah Approved for Adults with Relapsed or Refractory Large B-Cell Lymphoma
FDA Approvals, News & Updates
August 2018, Vol 9, No 2 | Payers’ Perspectives In Oncology: ASCO
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Erleada First Therapy Approved for Patients with Nonmetastatic Castration-Resistant Prostate Cancer
FDA Approvals, News & Updates
Web Exclusives
On February 14, 2018, apalutamide (Erleada; Janssen Pharmaceuticals), an androgen receptor inhibitor, received accelerated approval by the FDA for the treatment of patients with nonmetastatic, castration-resistant prostate cancer (CRPC). Apalutamide is the first treatment approved by the FDA for patients with nonmetastatic CRPC, and was approved under the FDA priority review process.
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Lynparza First Treatment Approved for Patients with Germline BRCA-Positive Metastatic Breast Cancer
FDA Approvals, News & Updates
Web Exclusives
On January 12, 2018, the FDA approved a new indication for olaparib (Lynparza; AstraZeneca) for the treatment of women with deleterious or suspected deleterious germline
BRCA
-positive, HER2-negative, metastatic breast cancer who received previous chemotherapy in the neoadjuvant, adjuvant, or metastatic setting.
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