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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.
For the second time this month, the FDA has given an approval to Genentech’s PD-L1 inhibitor, Tecentriq.
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.
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.
San Diego, CA—The 60th Annual Meeting of the American Society of Hematology drew more than 25,000 attendees from across the globe who were seeking information on the rapid pace of progress in hematology. Updates on the panoply of immunotherapies for B-cell malignancies, including chimeric antigen receptor (CAR) T-cell therapy, and the impressive progress made in the management of multiple myeloma and chronic lymphocytic leukemia (CLL) were highlighted in the scientific sessions.
San Diego, CA—Patients with relapsed, refractory, or high-risk hematologic malignancies obtained durable benefits with the combined checkpoint inhibition with nivolumab (Opdivo) and ipilimumab (Yervoy) as consolidation therapy after stem-cell transplant, according to results of a small prospective study presented at ASH 2018.
San Diego, CA—A 2-year duration of combination immunotherapy with ven­etoclax (Venclexta) and rituximab (Ri­tuxan) improved survival compared with standard-of-care chemoimmunotherapy combination with bendamustine (Ben­deka) plus rituximab in patients with relapsed or refractory chronic lymphocytic leukemia (CLL), according to follow-up data from the MURANO clinical trial presented at ASH 2018. Early results were first presented at ASH 2017.
San Diego, CA—An analysis of real-world administrative claims data in patients with chronic lymphocytic leukemia (CLL) has highlighted the need for treatments that result in fewer adverse events, according to data presented at ASH 2018.
San Diego, CA—Although chimeric antigen receptor (CAR) T-cell therapy has achieved remarkable long-lasting remissions in B-cell malignancies, in approximately 60% of the cases, the initial response wanes over time because of “immune exhaustion.”
San Diego, CA—A dizzying array of new chimeric antigen receptor (CAR) T-cell therapies targeting the B-cell maturation antigen (BCMA) designed specifically for the treatment of multiple myeloma was presented at ASH 2018. BCMA-targeted CAR T-cell therapies are designed to improve T-cell persistence, depth of response, and tolerability. Response rates reported at ASH 2018 range from 70% to 100%, depending on the patient population and the use of previous regimens.
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