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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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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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Enfortumab Vedotin Plus Pembrolizumab Approved For Urothelial Carcinoma

The FDA has granted accelerated approval to enfortumab vedotin-ejfv (Padcev®, Astellas Pharma) with pembrolizumab (Keytruda®, Merck) for treatment of locally advanced or metastatic urothelial carcinoma, specifically for patients who are ineligible for cisplatin-containing chemotherapy. "Both enfortumab vedotin and pembrolizumab are effective monotherapy treatments in patients with locally advanced or metastatic urothelial carcinoma," began Christopher Hoimes, Associate Professor of Medicine at t...

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Pirtobrutinib Granted Accelerated Approval for Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma

The FDA has granted accelerated approval to pirtobrutinib (Jaypirca®, Eli Lilly and Company) for adults with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who have received at least two prior lines of therapy, including a Bruton tyrosine kinase (BTK) inhibitor and a B-cell lymphoma 2 (BCL-2) inhibitor.   Why it matters: "Patients with CLL or SLL have poor outcomes after the failure of covalent BTK inhibitor treatment, and new therapeutic options are needed," wrote A...

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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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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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Cancer Drugs Given Accelerated Approval Lack Survival Benefit

​A recent study reports that only 20% of cancer drugs granted accelerated approval by the FDA ended up showing clinical benefit in terms of overall survival. Because it can take many years to assess a drug's clinical benefit as demonstrated through measures such as overall survival, in 1992 the FDA instituted the Accelerated Approval regulations, which permit drugs that fill an unmet medical need for serious conditions to be approved based on a surrogate end point. A surrogate end point is not i...

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