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FDA Expands Indication for Kadcyla to Include the Adjuvant Treatment of HER2-Positive Early Breast Cancer
Breast Cancer
,
FDA Approvals, News & Updates
,
In the News
,
Personalized Medicine
,
Solid Tumors
Web Exclusives
— May 14, 2019
On May 3, 2019, the US Food and Drug Administration (FDA) approved ado-trastuzumab emtansine (Kadcyla; Genentech) for the adjuvant treatment of patients with HER2-positive early breast cancer who have residual invasive disease after neoadjuvant taxane and trastuzumab-based treatment. Patients should be selected for treatment with this agent based on an FDA-approved companion diagnostic test (Ventana Medical System’s PATHWAY anti-HER-2/neu [4B5] Rabbit Monoclonal Primary Antibody assay or INFORM HER2 Dual ISH DNA Probe Cocktail assay).
Read Article
Ivosidenib Now FDA-Approved as First-Line Treatment for AML with IDH1 Mutation
FDA Approvals, News & Updates
,
In the News
Web Exclusives
— May 7, 2019
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.
Read Article
FDA Approves Pembrolizumab plus Axitinib for Advanced Renal-Cell Carcinoma
FDA Approvals, News & Updates
,
In the News
Web Exclusives
— April 23, 2019
Another Approval for Keytruda
Read Article
April 16, 2019 – FDA Approvals, News & Updates
FDA Approvals, News & Updates
Web Exclusives
— April 16, 2019
Keytruda Receives Expanded Indication for First-Line Treatment of Non–Small-Cell Lung Cancer
FDA Changes Recommended Contraception Period Following Soltamox Therapy
Read Article
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
— April 16, 2019
Read Article
FDA Approves First Hormonal-Based Therapy for Men with Advanced or Metastatic Breast Cancer
Breast Cancer
,
FDA Approvals, News & Updates
,
In the News
Web Exclusives
— April 5, 2019
On April 4, 2019, the US Food and Drug Administration (FDA) expanded the indication of palbociclib (Ibrance; Pfizer), a kinase inhibitor, in combination with specific endocrine therapies for men with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer. This is the first hormonal-based therapy to be approved for men.
Read Article
Proposed Landmark Policy Changes to Modernize Mammography and Raise Breast Density Awareness
Breast Cancer
,
FDA Approvals, News & Updates
,
In the News
Web Exclusives
— April 1, 2019
On March 27, 2019, the US Food and Drug Administration (FDA) issued an alert from its Office of Women’s Health announcing that, after more than 20 years of regulatory oversight, the agency is proposing amendments to the existing policy governing mammography services.
Read Article
FDA Approves Tecentriq plus Chemotherapy for First-Line Treatment of Extensive-Stage Small-Cell Lung Cancer
Lung Cancer
,
FDA Approvals, News & Updates
,
In the News
,
Solid Tumors
,
Personalized Medicine
Web Exclusives
— March 22, 2019
For the second time this month, the FDA has given an approval to Genentech’s PD-L1 inhibitor, Tecentriq.
Read Article
FDA Approves Tecentriq plus Abraxane—First Immunotherapy for PD-L1– Positive Unresectable Locally Advanced or Metastatic Triple-Negative Breast Cancer
FDA Approvals, News & Updates
,
In the News
Web Exclusives
— March 15, 2019
On March 8, 2019, the FDA granted accelerated approval to Genentech’s Tecentriq (atezolizumab), in combination with nab-paclitaxel (Abraxane), for the treatment of PD-L1–positive unresectable locally advanced or metastatic triple-negative breast cancer (TNBC). This marks the first time an immunotherapy drug has been granted approval for the treatment of any form of breast cancer.
Read Article
March 08, 2019 - FDA Approvals, News & Updates
FDA Approvals, News & Updates
Web Exclusives
— March 8, 2019
Approvals for new delivery methods for Herceptin and Cinvanti, and a new indication for Lonsurf close out the month of February in the FDA’s oncology-related activity.
Read Article
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