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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Nivolumab Plus Fluoropyrimidine and Platinum-Based Chemotherapy and Nivolumab Plus Ipilimumab Approved for Esophageal Squamous Cell Carcinoma

The FDA has approved nivolumab (Opdivo®, Bristol Myers Squibb) in combination with fluoropyrimidine with platinum-based chemotherapy, and nivolumab in combination with ipilimumab (Yervoy®, Bristol Myers Squibb) for treatment of patients with advanced or metastatic esophageal squamous cell carcinoma (ESCC). "Esophageal cancer causes more than half a million cancer-related deaths worldwide each year, with squamous cell carcinoma accounting for approximately 85% of cases," wrote Yuichiro Doki, MD, ...

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Selpercatinib Approved for RET Fusion–Positive Solid Tumors

The FDA has granted accelerated approval to selpercatinib (Retevmo®, Eli Lilly and Company) for treatment of adult patients with locally advanced or metastatic rearranged during transfection (RET) gene fusion solid tumors that have progressed on prior systemic therapy, or who have no adequate alternative treatment options. "Selpercatinib, a highly selective RET kinase inhibitor with central nervous system (CNS) activity, was developed specifically to treat patients with RET-altered cancers," wro...

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Crizotinib Approved for Treatment of ALK-Positive Inflammatory Myofibroblastic Tumors

The FDA has granted approval to crizotinib (Xalkori®, Pfizer) for treatment of unresectable, recurrent, or refractory inflammatory anaplastic lymphoma kinase (ALK)–positive inflammatory myofibroblastic tumors (IMTs) in adult or pediatric patients one year and older. "ALK is a receptor tyrosine kinase (RTK) that is known to be oncogenically activated by point mutations within the tyrosine kinase domain, copy-number amplification, or chromosomal translocations" wrote Jennifer Foster, MD, MPH, Dire...

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Umbralisib Withdrawn for Marginal Zone Lymphoma and Follicular Lymphoma

The FDA has announced that it has withdrawn its approval of umbralisib (Ukoniq®, TG Therapeutics) for treatment of marginal zone lymphoma (MZL) and follicular lymphoma (FL). Umbralisib had previously been granted accelerated approval in February 2021 based on the UNITY-NHL trial (NCT02793583). The withdrawal of this treatment was determined due to updated data from the UNITY-CLL trial (NCT02612311), which revealed a possible increased risk of death in patients receiving umbralisib. TG Therapeuti...

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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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Romidepsin Withdrawn for Peripheral T-Cell Lymphoma

Bristol Myers Squibb has recently made the decision to withdraw romidepsin (Istodax®, Celgene Corporation) from the treatment of patients with peripheral T-cell lymphoma (PTCL) in the United States. In 2011, romidepsin received accelerated approval as monotherapy for the treatment of patients with PTCL. The reason for the withdrawal is due to the results of a phase 3 confirmatory study (NCT01796002), a multicenter trial that randomized 421 patients with previously untreated PTCL to receive romid...

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Single-Agent Nivolumab Withdrawn for Hepatocellular Carcinoma Treatment

In consultation with the FDA, Bristol Myers Squibb has voluntarily withdrawn nivolumab (Opdivo®) as a single-agent treatment for patients with hepatocellular carcinoma (HCC) who had previously been treated with sorafenib. Nivolumab had previously been granted accelerated approval from the FDA in 2017, which was based on the phase 1/2 CheckMate 040 clinical trial (NCT01658878). The withdrawal of this treatment is due to the lack of statistical significance in the final overall survival results of...

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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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Pembrolizumab Approval Withdrawn for Third-Line Gastric Cancer Treatment

Yesterday, Merck announced that it will voluntarily withdraw the accelerated approval indication of pembrolizumab (Keytruda®, Merck) for patients with recurrent locally advanced/metastatic gastric or gastroesophageal junction adenocarcinoma whose tumors express programmed death-ligand 1 (PD-L1) with a combined positive score (CPS) ≥1 and who experienced disease progression on or after two or more prior lines of therapy, including fluoropyrimidine- and platinum-containing chemotherapy and human e...

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Durvalumab Approval Withdrawn for Urothelial Carcinoma

Today, AstraZeneca voluntarily withdrew the indication of durvalumab (Imfinzi®, AstraZeneca) for patients with previously treated locally advanced or metastatic urothelial carcinoma based on results of the phase 3 DANUBE trial (NCT02516241), which did not meet its primary end points. The withdrawal does not affect durvalumab's indications for non-small cell lung cancer or for extensive stage small-cell lung cancer. Durvalumab, a human monoclonal antibody that binds to programmed death ligand 1 (...

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Tirbanibulin FDA Approved for Actinic Keratosis

The FDA has now approved tirbanibulin (Klisyri®, Athenex) for treating actinic keratosis (AK) on the face or scalp topically. Actinic keratosis is a precancerous lesion that forms on skin that has been damaged by long-term, chronic exposure to ultraviolet rays from the sun and/or indoor tanning. As the second most common diagnosis made by dermatologists in the US, AK will develop into skin cancers 10%-15% of the time when left untreated. Approval was based on effective results shown in two pivot...

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Pembrolizumab FDA Approved for Triple-Negative Breast Cancer

The FDA recently approved pembrolizumab (Keytruda®, Merck & Co) with chemotherapy for patients with locally recurrent unresectable or metastatic triple-negative breast cancer (TNBC) for those whose tumors express PD-L1 (CPS ≥10) as determined by an FDA approved test. In addition, the FDA approved the companion diagnostic, PD-L1 IHC 22C3 pharmDx (Dako North America, Inc.), to select patients with TNBC for pembrolizumab. Efficacy was shown in KEYNOTE-355 (NCT02819518), a multicenter, double-bl...

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FDA Issues Draft Guidances for Bladder Cancer, Renal Cell Carcinoma

The FDA has issued draft guidance documents for drug and biologic development in the adjuvant treatment of renal cell carcinoma (RCC) and bladder cancer, with recommendations for clinical trials concerning eligibility criteria, methodology, and use of disease-free survival as an end point. "The FDA has actively encouraged a more uniform approach to developing clinical trials to evaluate adjuvant treatments for renal cell carcinoma and bladder cancer, including hosting a public workshop in p...

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Avelumab for Urothelial Carcinoma: An Interview With Thomas Powles, MBBS, MRCP, MD

The FDA recently approved avelumab (Bavencio®, EMD Serono, Inc.) for patients with advanced urothelial carcinoma (UC). Thomas Powles, MBBS, MRCP, MD, discusses with i3 Health the implication of this approval and future steps for research and offers community oncologists advice on treating this patient population. What are the most challenging aspects of treating patients with locally advanced or metastatic UC? Thomas Powles, MBBS, MRCP, MD: The overall survival outcomes are poor for the disease....

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FDA Approves Pembrolizumab for Cutaneous Squamous Cell Carcinoma

For patients with recurrent or metastatic cutaneous squamous cell carcinoma (cSCC), pembrolizumab (Keytruda®, Merck & Co., Inc.) is now FDA approved. An immunotherapy originally approved for advanced non-small cell lung cancer, melanoma, high-risk non-muscle invasive bladder cancer, and advanced cervical cancer, among others, pembrolizumab targets the programmed death (PD-1) pathway to prevent cancer cells from hiding. This allows the body's T cells to attack and kill cancer cells. Approval ...

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Selinexor Approved for R/R Diffuse Large B-Cell Lymphoma

Accelerated approval was granted to selinexor (Xpovio®, Karyopharm Therapeutics) to treat adult patients with relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL), including those with DLBCL resulting from follicular lymphoma, after receiving at least two prior lines of systemic therapy. Selinexor had previously been approved in combination with dexamethasone for adult patients with R/R multiple myeloma who were previously treated with at least four therapies and whose disease is refr...

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