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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.
Web Exclusives published on October 15, 2019 in FDA Updates, In the News, NCCN
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.
Web Exclusives published on September 30, 2019 in FDA Updates, Multiple Myeloma, In the News
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.
Web Exclusives published on September 11, 2019 in Renal-Cell Carcinoma
Chicago, IL—The results of a phase 3 clinical trial support the use of avelumab (Bavencio) plus axitinib (Inlyta) as a new first-line standard-of-care treatment for patients with newly diagnosed advanced renal-cell carcinoma. According to data presented at ASCO 2019, JAVELIN Renal 101 demonstrated longer progression-free survival (PFS) and higher overall response rates for the combination of avelumab with axitinib versus sunitinib (Sutent) monotherapy for treatment-naïve patients with advanced renal-cell carcinoma. The benefit was not limited only to the first-line setting. Patients who received avelumab plus axitinib also had longer PFS after second-line treatment and a longer mean duration of response than patients who received sunitinib alone.
Web Exclusives published on September 11, 2019 in FDA Updates, Lymphoma
On June 10, 2019, the FDA granted accelerated approval to polatuzumab vedotin-piiq (Polivy; Genentech), a CD79b-directed antibody–drug conjugate, in combination with bendamustine (Bendeka, Treanda) plus rituximab (Rituxan or a biosimilar), for the treatment of patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who have received ≥2 lines of therapy. The FDA granted polatuzumab breakthrough therapy and orphan drug designations.
Web Exclusives published on August 1, 2019 in Multiple Myeloma
San Diego, CA—Analysis of healthcare utilization among Medicare beneficiaries with multiple myeloma suggests that the setting of autologous hematopoietic stem-cell transplantation (HSCT) has a significant impact on provider reimbursement and out-of-pocket expenses for patients, according to data presented at ASH 2018.

Web Exclusives published on July 29, 2019 in ASCO
The FDA has announced the launch of an oncology-specific pilot program for physicians and patients who need access to investigational therapies.
Web Exclusives published on July 29, 2019 in Immunotherapy
Chimeric antigen receptor (CAR) T-cell therapy is a type of immunotherapy that uses a patient’s own genetically modified T-cells to fight cancer.
Web Exclusives published on June 26, 2019 in FDA Updates, In the News
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.
Web Exclusives published on June 12, 2019 in FDA Updates, In the News
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.
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