FDA Approves Pembrolizumab Combination for Cervical Cancer

The FDA has granted approval to pembrolizumab (Keytruda®, Merck) in combination with chemotherapy, with or without bevacizumab, for patients with persistent, recurrent, or metastatic cervical cancer whose tumors express programmed death-ligand 1 (PD-L1). The FDA has also granted regular approval to single-agent pembrolizumab for patients with recurrent or metastatic cervical cancer whose tumors express PD-L1, with a combined positive score of ≥1, who experienced disease progression on or after c...
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Atezolizumab Indication Withdrawn from Triple-Negative Breast Cancer Treatment

In consultation with the FDA, the accelerated approval of atezolizumab (Tecentriq®, Genentech) in combination with nab-paclitaxel has been voluntarily withdrawn from the treatment of patients with programmed death ligand 1 (PD-L1)–positive unresectable locally advanced or metastatic triple-negative breast cancer (TNBC). "Triple-negative breast cancer is a heterogenous disease entity with a high unmet medical need," wrote David Miles, MD, Lead Clinician for Breast Cancer at Mount Vernon Cancer Ce...
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Improving the Management of Metastatic Breast Cancer: A Conversation With Dr. Sara Tolaney

Keira Smith: Hi, I'm Keira Smith from Oncology Data AdvisorTM. I'm here today with Dr. Sara Tolaney. Sara Tolaney, MD, MPH: Thanks so much for having me. I'm Sara Tolaney. I'm a breast medical oncologist at Dana-Farber Cancer Institute here in Boston. Keira Smith: Thank you so much for joining us, Dr. Tolaney. So what are some of the most challenging aspects of managing patients with metastatic breast cancer? Dr. Tolaney: I think we've made incredible progress for our patients with metastatic br...
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FDA Issues Survival Alert for Melphalan Flufenamide in Multiple Myeloma Treatment

The FDA has issued an alert that melphalan flufenamide (Pepaxto®, Oncopeptides AB) in combination with dexamethasone has demonstrated an increased risk of death in the OCEAN trial (NCT03151811) of patients with multiple myeloma. Melphalan flufenamide plus dexamethasone was granted accelerated approval in February 2021 for patients with relapsed/refractory multiple myeloma who have been treated with at least four prior lines of therapy and whose disease is refractory to at least one proteasome in...
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FDA Approves Daratumumab and Hyaluronidase-Fihj With Chemo and Steroid for Multiple Myeloma

The FDA has granted approval to daratumumab and hyaluronidase-fihj (Darzalex Faspro®, Janssen Biotech, Inc.) in combination with pomalidomide and dexamethasone for patients with multiple myeloma who have received at least one prior line of therapy, including lenalidomide and a proteasome inhibitor. "In a phase 1b study, intravenous daratumumab plus pomalidomide and dexamethasone induced a very good partial response," wrote Meletios A. Dimopoulos, MD, Professor and Chairman of the Department of C...
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