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FDA Approvals, News & Updates
FDA Approvals, News & Updates
Herceptin Hylecta a New Subcutaneous Injection Approved for Patients with HER2-Positive Breast Cancer
Breast Cancer
,
FDA Approvals, News & Updates
April 2019, Vol 10, No 2
On February 28, 2019, the FDA approved a combination of the HER2/
neu
receptor agonist trastuzumab plus the endoglycosidase hyaluronidase-oysk (Herceptin Hylecta; Genentech) subcutaneous (SC) injection for adults with HER2-overexpressing breast cancer in the adjuvant setting, as part of a regimen with chemotherapy or as monotherapy after multimodality anthracycline-based therapy; and as first-line treatment for metastatic disease, in combination with paclitaxel, or as monotherapy after ≥1 chemotherapies in the metastatic setting. This SC injection is a new formulation of intravenous (IV) trastuzumab.
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Lonsurf Approved for Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma
FDA Approvals, News & Updates
April 2019, Vol 10, No 2
On February 22, 2019, the FDA approved a new indication for trifluridine plus tipiracil (Lonsurf; Taiho Pharmaceuticals), an oral combination of a nucleoside metabolic inhibitor and a thymidine phosphorylase inhibitor for the treatment of patients with metastatic gastric or gastroesophageal junction adenocarcinoma who received ≥2 lines of chemotherapy regimens with a fluoropyrimidine, a platinum, a taxane or irinotecan, and, if appropriate, HER2/
neu
-targeted therapy. The FDA used its priority review process for this new indication and granted it an orphan drug designation. Trifluridine plus tipiracil was previously approved for metastatic colorectal cancer.
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Keytruda Approved for Adjuvant Treatment for Patients with Melanoma
FDA Approvals, News & Updates
April 2019, Vol 10, No 2
On February 15, 2019, the FDA approved pembrolizumab (Keytruda; Merck) for the adjuvant treatment of patients with melanoma and involvement of lymph node(s) after a complete resection. This is the second melanoma-related indication for pembrolizumab, which was previously approved by the FDA for the treatment of patients with unresectable or metastatic melanoma.
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Keytruda plus Alimta Combination Approved for First-Line Therapy of Metastatic NSCLC
FDA Approvals, News & Updates
April 2019, Vol 10, No 2
On January 31, 2019, the FDA approved the combination of pemetrexed (Alimta; Eli Lilly) plus pembrolizumab (Keytruda; Merck) and platinum-based chemotherapy for first-line treatment of patients with metastatic nonsquamous non–small-cell lung cancer (NSCLC) and no
EGFR
or
ALK
mutations.
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Imbruvica plus Gazyva Approved as First-Line Treatment for CLL/SLL
FDA Approvals, News & Updates
April 2019, Vol 10, No 2
On January 28, 2019, the FDA approved the combination of the oral Bruton’s tyrosine kinase inhibitor ibrutinib (Imbruvica; Pharmacyclics), plus the CD20-directed cytolytic antibody obinutuzumab (Gazyva; Genentech), for the treatment of adults with untreated chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). Imbruvica was already approved as a single agent for different indications, including for adults with CLL or SLL, with or without 17p deletion.
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Cabometyx Now Indicated for Hepatocellular Carcinoma
FDA Approvals, News & Updates
April 2019, Vol 10, No 2
On January 14, 2019, the FDA approved a new indication for cabozantinib (Cabometyx; Exelixis), an oral multitargeted tyrosine kinase inhibitor, for the treatment of patients with hepatocellular carcinoma who had previously received treatment with sorafenib (Nexavar).
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Ivosidenib Now FDA-Approved as First-Line Treatment for AML with IDH1 Mutation
FDA Approvals, News & Updates
,
In the News
Web Exclusives
On May 2, 2019, the US Food and Drug Administration (FDA) approved ivosidenib (Tibsovo; Agios Pharmaceuticals, Inc) for the treatment of newly diagnosed acute myeloid leukemia (AML) with a susceptible
IDH1
mutation, as detected by an FDA-approved companion diagnostic test, in patients who are aged ≥75 years or who have comorbidities that preclude the use of intensive induction chemotherapy.
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FDA Approves Pembrolizumab plus Axitinib for Advanced Renal-Cell Carcinoma
FDA Approvals, News & Updates
,
In the News
Web Exclusives
Another Approval for Keytruda
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April 16, 2019 – FDA Approvals, News & Updates
FDA Approvals, News & Updates
Web Exclusives
Keytruda Receives Expanded Indication for First-Line Treatment of Non–Small-Cell Lung Cancer
FDA Changes Recommended Contraception Period Following Soltamox Therapy
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Adding Pegylated Interferon to Nilotinib Enhances Molecular Response in Chronic-Phase Chronic Myeloid Leukemia
By
Wayne Kuznar
Leukemia
,
FDA Approvals, News & Updates
,
Hematologic Malignancies
Web Exclusives
Read Article
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Home
Issues
Online First
Latest Issue
Issue Archive
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Personalized Medicine
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Cholangiocarcinoma
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Conference Correspondent
SABCS 2023 - HER2+ MBC
ASCO 2023 - Breast Cancer
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Prostate Cancer Diagnostics Monthly Minutes
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