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FDA Updates
October 28, 2019 – Oncology News & Updates
FDA Updates
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In the News
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Ovarian Cancer
Web Exclusives
Zejula Now Approved for Late-Line Ovarian Cancer
Trump Set to Nominate Hahn as FDA Commissioner
FDA Aims to Improve Breast Implant Guidance
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Vincristine, Racial Disparities in Multiple Myeloma, and HER2 Metastatic Breast Cancer Are in the News
Breast Cancer
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FDA Updates
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In the News
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Multiple Myeloma
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Pediatric Cancer
Web Exclusives
The past week in oncology-related news includes shortages of crucial pediatric cancer drug, results of a study of racial disparities in multiple myeloma, and new drug on the horizon for HER2 metastatic breast cancer.
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FDA on In Vitro Diagnostics, Vaping; Cost of Novel Treatments
FDA Updates
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In the News
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NCCN
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NCCN News
Web Exclusives
FDA issues finalized guidelines for use of in vitro diagnostics in oncology drug trials and warnings on vaping; new findings report patients bear more costs when MBC treatment is not concordant with NCCN guidelines.
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FDA Approves Inrebic for the Treatment of Patients with Myelofibrosis
FDA Updates
TON - October 2019, Vol 12, No 5
On August 16, 2019, the FDA approved fedratinib (Inrebic; Celgene) for the treatment of patients with intermediate-2 or high-risk primary or secondary (post–polycythemia vera or post–essential thrombocythemia) myelofibrosis.
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Darzalex Combination Receives Approval for First-Line Treatment of Patients with Multiple Myeloma Eligible for Transplant
FDA Updates
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Multiple Myeloma
,
In the News
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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FDA Approves Polivy in Combination with Bendamustine plus Rituximab for Patients with Relapsed, Refractory DLBCL
FDA Updates
TON - August 2019, Vol 12, No 4
On June 10, 2019, the FDA accelerated the approval of polatuzumab vedotin-piiq (Polivy; Genentech), a CD79b-directed antibody-drug conjugate, in combination with bendamustine (Bendeka, Treanda) plus rituximab (Rituxan or a biosimilar; BR) for the treatment of patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after ≥2 previous therapies.
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Xpovio plus Dexamethasone Combination Receives Accelerated Approval for the Treatment of Patients with Relapsed or Refractory MM
FDA Updates
TON - August 2019, Vol 12, No 4
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 (MM) who had received ≥4 previous therapies and whose disease is resistant to several other forms of treatment, including ≥2 proteasome inhibitors, ≥2 immunomodulatory agents, and an anti-CD38 monoclonal antibody.
Read More ›
Keytruda Approved for Patients with Previously Treated Metastatic Small-Cell Lung Cancer
By
Yvette Florio Lane
FDA 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.
Read More ›
FDA News
FDA Updates
TON - June 2019, Vol 12, No 3
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First Chemoimmunotherapy Regimen Granted Accelerated Approval for Patients with Previously Treated DLBCL
By
Yvette Florio Lane
FDA Updates
,
In the News
Web Exclusives
On June 10, 2019, the US Food and Drug Administration (FDA) granted accelerated approval to the novel antibody-drug conjugate polatuzumab vedotin-piiq (Polivy; Genentech) in combination with bendamustine plus rituximab for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) that has progressed or returned after at least 2 previous therapies. This is the first chemoimmunotherapy regimen approved for use in patients with DLBCL who are ineligible for hematopoietic stem-cell transplantation.
Read More ›
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