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Accelerated Approvals in Oncology: Benefits, Risks, and the Way Forward With Dr. Jason Mouabbi, Dr. Ross Maclean, and Michael Glover

Oncology Data Advisor® · Accelerated Approvals in Oncology: Benefits, Risks, and the Way Forward In this interview, Dr. Jason Mouabbi, OncData Editorial Board Member and Breast Medical Oncologist at MD Anderson Cancer Center, speaks with Dr. Ross Maclean and Michael Glover about the debate surrounding accelerated FDA approvals, including their benefits, risks, and ways that physicians, patients, pharmaceutical companies, and the FDA can collaborate to maximize the impact of accelerate...

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Do Accelerated Approvals Really Benefit Patients? With Ravi Parikh, MD, MPP

Oncology Data Advisor™ · Do Accelerated Approvals Really Benefit Patients? With Ravi Parikh, MD, MPP Recently, Ravi Parikh, MD, MPP, an Assistant Professor of Medical Ethics and Health Policy and Medicine at the University of Pennsylvania, Perelman School of Medicine, released a research letter titled, "Exposure to US Cancer Drugs With Lack of Confirmed Benefit After US Food and Drug Administration Accelerated Approval." In this interview with OncData, he further discusses his resea...

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Accelerated Approvals in Oncology: Benefits, Risks, and the Way Forward With Dr. Jason Mouabbi, Dr. Ross Maclean, and Michael Glover

In this interview, Dr. Jason Mouabbi, OncData Editorial Board Member and Breast Medical Oncologist at MD Anderson Cancer Center, speaks with Dr. Ross Maclean and Michael Glover about the debate surrounding accelerated FDA approvals, including their benefits, risks, and ways that physicians, patients, pharmaceutical companies, and the FDA can collaborate to maximize the impact of accelerated approval drugs.  

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Osimertinib Plus Platinum-Based Chemotherapy Approved for Locally Advanced or Metastatic Non–Small Cell Lung Cancer

The FDA has granted approval to osimertinib (Tagrisso®, AstraZeneca Pharmaceuticals LP) with platinum-based chemotherapy for patients with locally advanced or metastatic non–small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test.   Why it matters: "Osimertinib is a third-generation epidermal growth factor receptor-tyrosine kinase inhibitor (EGFR-TKI) that is selective for EGFR...

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Lifileucel Granted Accelerated Approval for Unresectable or Metastatic Melanoma

The FDA has granted accelerated approval to lifileucel (Amtagvi, Iovance Biotherapeutics, Inc.) for adult patients with unresectable or metastatic melanoma previously treated with a programmed cell death protein 1 (PD-1) blocking antibody, and if BRAF V600–positive, a BRAF inhibitor with or without a mitogen-activated protein kinase (MEK) inhibitor. Lifileucel is a tumor-derived autologous T-cell immunotherapy and is the first cellular therapy to receive an approval for solid tumors.   Why ...

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Tepotinib Granted Traditional Approval for Metastatic Non–Small Cell Lung Cancer

The FDA has granted traditional approval to tepotinib (Tepmetko®, EMD Serono, Inc.) for adult patients with metastatic non–small cell lung cancer (NSCLC) harboring mesenchymal-epithelial transition (MET) exon 14 skipping alterations. Tepotinib was previously granted accelerated approval for this indication on February 3, 2021.   Why it matters: "MET inhibitors have recently demonstrated clinical activity in patients with MET exon 14–skipping NSCLC; however, data with longer follow-up and in...

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Irinotecan Liposome Approved for First-Line Metastatic Pancreatic Adenocarcinoma Treatment

The FDA has approved irinotecan liposome (Onivyde®, Ipsen Biopharmaceuticals, Inc.) with oxaliplatin, fluorouracil, and leucovorin, for the first-line treatment of metastatic pancreatic adenocarcinoma.   Why it matters: "The approval of liposomal irinotecan in combination with standard-of-care agents provides clinicians and patients with another option for first-line treatment of metastatic pancreatic cancer," wrote Joseph Kalis, PharmD, BCOP, an Ambulatory Oncology Pharmacy Specialist at t...

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Enfortumab Vedotin-ejfv Plus Pembrolizumab Approved for Urothelial Cancer

The FDA has approved enfortumab vedotin-ejfv (Padcev®, Astellas Pharma) in combination with pembrolizumab (Keytruda®, Merck) for patients with locally advanced or metastatic urothelial cancer (UC). The FDA previously granted accelerated approval for this therapy combination for patients with locally advanced or metastatic UC who are ineligible for cisplatin-containing chemotherapy.   Why it matters: "Cisplatin-based combination chemotherapy remains the standard of care for locally advanced ...

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Pembrolizumab Approved for Biliary Tract Cancer

The FDA has approved pembrolizumab (Keytruda®, Merck) in combination with gemcitabine and cisplatin for locally advanced unresectable or metastatic biliary tract cancer (BTC).   Why it matters: "Biliary tract cancers, which arise from the intrahepatic or extrahepatic bile ducts and the gallbladder, generally have a poor prognosis and are rising in incidence worldwide," wrote Robin Kate Kelley, MD, a Gastrointestinal Oncologist at The University of California, San Francisco, and colleagues, ...

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Toripalimab-tpzi Approved for Nasopharyngeal Carcinoma

The FDA has approved toripalimab-tpzi (Loqtorzi™, Coherus BioSciences, Inc.) in combination with cisplatin and gemcitabine for first-line treatment of metastatic or recurrent, locally advanced nasopharyngeal carcinoma (NPC). Additionally, the FDA approved toripalimab-tpzi as a single agent for treatment of recurrent unresectable or metastatic NPC with disease progression on or after a platinum-containing chemotherapy. Toripalimab is a humanized immunoglobulin G (IgG) antibody for programmed cell...

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Melphalan Approved for Liver-Directed Treatment for Uveal Melanoma

The FDA has approved melphalan for injection (Hepzato Kit™/Hepatic Delivery System), containing melphalan (Hepzato™, Delcath Systems, Inc.) as a liver-directed treatment for patients with uveal melanoma with unresectable hepatic metastases affecting ≤50% of the liver. This treatment is permitted for those with no extrahepatic disease, or extrahepatic disease limited to the bone, lymph nodes, subcutaneous tissues, or lung that is amenable to resection or radiation. This application was granted or...

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Elranatamab-bcmm Granted Accelerated Approval for Multiple Myeloma

The FDA granted accelerated approval to elranatamab-bcmm (Elrexfio™, Pfizer, Inc.) for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, including one proteasome inhibitor, one immunomodulatory agent, and one anti-CD38 monoclonal antibody. Elranatamab-bcmm is a bispecific B-cell maturation antigen (BCMA)-directed CD3 T-cell engager.   Why it matters: "Elranatamab is a humanized bispecific antibody that target...

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Niraparib and Abiraterone Acetate Plus Prednisone Approved for BRCA-Mutated Metastatic CRPC

The FDA has approved the fixed dose combination of niraparib and abiraterone acetate (Akeega™, Janssen Biotech), plus prednisone, for adult patients with deleterious or suspected deleterious BRCA-mutated metastatic castration-resistant prostate cancer (CRPC), as identified by an FDA-approved test.   Why it matters: "Metastatic CRPC remains a lethal disease, highlighting a need for new therapies," wrote Kim N. Chi, MD, Professor in the Division of Medical Oncology at the University of Britis...

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Talquetamab-tgvs Granted Accelerated Approval for Relapsed/Refractory Multiple Myeloma

The FDA has granted accelerated approval to talquetamab-tgvs (Talvey™, Janssen Biotech, Inc.) for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least 4 prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.   Why it matters: "G protein–coupled receptor, family C, group 5, member D (GPRC5D) is an orphan receptor expressed in malignant plasma cells," wrote Ajai Chari, Direct...

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Quizartinib Approved for Newly Diagnosed Acute Myeloid Leukemia

The FDA has approved quizartinib (Vanflyta®, Daiichi Sankyo, Inc.) for treatment of adult patients with newly diagnosed acute myeloid leukemia (AML) that is FLT3 internal tandem duplication (ITD)-positive, as detected by the FDA's newly approved companion diagnostic for quizartinib, LeukoStrat CDx FLT3 Mutation Assay. Quizartinib is added to standard cytarabine and anthracycline induction therapy, cytarabine consolidation therapy, and maintenance quizartinib monotherapy following consolidation c...

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Do Accelerated Approvals Really Benefit Patients? With Ravi Parikh, MD, MPP

Recently, Ravi Parikh, MD, MPP, an Assistant Professor of Medical Ethics and Health Policy and Medicine at the University of Pennsylvania, Perelman School of Medicine, released a research letter titled, "Exposure to US Cancer Drugs With Lack of Confirmed Benefit After US Food and Drug Administration Accelerated Approval." In this interview with OncData, he further discusses his research and gives a thought-provoking analysis of what these findings could mean for the future of the accelerated app...

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Pirtobrutinib Granted Accelerated Approval for Mantle Cell Lymphoma

The FDA has granted accelerated approval to pirtobrutinib (Jaypirca™, Eli Lilly and Company) for patients with relapsed or refractory mantle cell lymphoma (MCL) following a minimum of two lines of systemic therapy that included a Bruton tyrosine kinase inhibitor (BTKi). "Pirtobrutinib, a highly selective, non-covalent (reversible) BTKi, inhibits both wildtype and C481-mutant BTK with equal low nanomolar (nM) potency, and has favorable oral pharmacology that enables continuous BTK inhibition thro...

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FDA Oncology Approvals in 2022: Timeline of Novel Treatment Options

The past year has been filled with new and exciting improvements and novel treatment options in the field of oncology and hematology. The FDA has granted approval and accelerated approval to many new drugs and drug combinations, including the very first approval for patients with HER2-mutant non–small cell lung cancer, trastuzumab deruxtecan. This is a great time to reflect on the current treatment landscape and ponder what 2023 could have in store for future approvals and emerging treatment opt...

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Mosunetuzumab-axgb Approved for Relapsed/Refractory Follicular Lymphoma

The FDA has granted accelerated approval to mosunetuzumab-axgb (Lunsumio™, Genentech) for adult patients with relapsed or refractory follicular lymphoma (FL) who have previously received at least two lines of systemic therapy. "Mosunetuzumab is a CD20 x CD3 T-cell–engaging bispecific monoclonal antibody that redirects T cells to eliminate malignant B cells," wrote L. Elizabeth Budde, MD, PhD, Associate Professor in the Department of Hematology & Hematopoietic Cell Transplantation at City of ...

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Futibatinib Receives Accelerated Approval for Cholangiocarcinoma

The FDA has granted accelerated approval to futibatinib (Lytgobi®, Taiho Oncology, Inc.) for treatment of previously treated, unresectable, locally advanced, or metastatic intrahepatic cholangiocarcinoma (iCCA) with fibroblast growth factor receptor 2 (FGFR2) gene fusions or rearrangements. "Survival outcomes are historically poor in patients with advanced/metastatic iCCA, with median overall survival times of approximately one year with first-line gemcitabine plus cisplatin and approximately si...

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