In cooperation with the Food and Drug Administration (FDA), and as a service to our members, NNECOS will periodically distribute information about newly approved therapies for cancer patients.  This helps FDA to inform oncologists and professionals in oncology-related fields of recent approvals in a timely manner.  Please note the link to the FDA information providing relevant clinical information, contraindications, dosing, and safety.  In providing this information, NNECOS does not endorse any product or therapy and does not take any position on the safety or efficacy of the product or therapy described. If you have questions about billing or reimbursement for these drugs, we recommend you visit our Regional Reimbursement Page to contact a representative of the manufacturer for assistance.

Please visit the FDA Hematology/Oncology (Cancer) Approvals & Safety Notifications webpage for a list of current and past approvals.

FDA grants accelerated approval to pirtobrutinib for chronic lymphocytic leukemia and small lymphocytic lymphoma

On December 1, 2023, the Food and Drug Administration granted accelerated approval to pirtobrutinib (Jaypirca, Eli Lilly and Company) for adults with chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) who have received at least two prior lines of therapy, including a BTK inhibitor and a BCL-2 inhibitor.

More Information: https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-pirtobrutinib-chronic-lymphocytic-leukemia-and-small-lymphocytic

FDA approves nirogacestat for desmoid tumors

On November 27, 2023, the Food and Drug Administration approved nirogacestat (OGSIVEO, SpringWorks Therapeutics, Inc.) for adult patients with progressing desmoid tumors who require systemic treatment. This is the first approved treatment for desmoid tumors.

More Information: https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-nirogacestat-desmoid-tumors

FDA approves capivasertib with fulvestrant for breast cancer

On November 16, 2023, the Food and Drug Administration approved capivasertib (Truqap, AstraZeneca Pharmaceuticals) with fulvestrant for adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer with one or more PIK3CA/AKT1/PTEN-alterations, as detected by an FDA-approved test, following progression on at least one endocrine-based regimen in the metastatic setting or recurrence on or within 12 months of completing adjuvant therapy.

More Information: https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-capivasertib-fulvestrant-breast-cancer

FDA approves enzalutamide for non-metastatic castration-sensitive prostate cancer with biochemical recurrence

On November 16, 2023, the Food and Drug Administration approved enzalutamide (Xtandi, Astellas Pharma US, Inc.) for non-metastatic castration-sensitive prostate cancer (nmCSPC) with biochemical recurrence at high risk for metastasis (high-risk BCR).

More Information: https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-enzalutamide-non-metastatic-castration-sensitive-prostate-cancer-biochemical-recurrence

FDA approves pembrolizumab with chemotherapy for HER2-negative gastric or gastroesophageal junction adenocarcinoma

On November 16, 2023, the Food and Drug Administration approved pembrolizumab (Keytruda, Merck) with fluoropyrimidine- and platinum-containing chemotherapy for the first-line treatment of adults with locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma.

More Information: https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-pembrolizumab-chemotherapy-her2-negative-gastric-or-gastroesophageal-junction

FDA approves repotrectinib for ROS1-positive non-small cell lung cancer 

On November 15, 2023, the Food and Drug Administration approved repotrectinib (Augtyro, Bristol-Myers Squibb Company) for locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC).

More Information: https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-repotrectinib-ros1-positive-non-small-cell-lung-cancer

FDA approves pembrolizumab with chemotherapy for biliary tract cancer

On October 31, 2023, the Food and Drug Administration approved pembrolizumab (Keytruda, Merck) to be used with gemcitabine and cisplatin for locally advanced unresectable or metastatic biliary tract cancer (BTC).

More Information: https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-pembrolizumab-chemotherapy-biliary-tract-cancer

FDA approves toripalimab-tpzi for nasopharyngeal carcinoma

On October 27, 2023, the Food and Drug Administration approved toripalimab-tpzi (LOQTORZ, Coherus BioSciences, Inc.) with cisplatin and gemcitabine for the first-line treatment of adults with metastatic or recurrent, locally advanced nasopharyngeal carcinoma (NPC). FDA also approved toripalimab-tpzi as a single agent for adults with recurrent unresectable or metastatic NPC with disease progression on or after a platinum-containing chemotherapy.

More Information: https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-toripalimab-tpzi-nasopharyngeal-carcinoma

FDA approves ivosidenib for myelodysplastic syndromes

On October 24, 2023, the Food and Drug Administration approved ivosidenib (Tibsovo, Servier Pharmaceuticals LLC) for adult patients with relapsed or refractory myelodysplastic syndromes (MDS) with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation, as detected by an FDA-approved test.

More Information: https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-ivosidenib-myelodysplastic-syndromes

FDA expands pediatric indication for entrectinib and approves new pellet formulation

On October 20, 2023, the Food and Drug Administration granted accelerated approval to entrectinib (Rozlytrek, Genentech Inc.) for pediatric patients older than 1 month with solid tumors that have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion without a known acquired resistance mutation, are metastatic or where surgical resection is likely to result in severe morbidity, and have progressed following treatment or have no satisfactory standard therapy. In August 2019, FDA granted accelerated approval to entrectinib for pediatric patients 12 years of age and older for this indication.

More Information: https://www.fda.gov/drugs/resources-information-approved-drugs/fda-expands-pediatric-indication-entrectinib-and-approves-new-pellet-formulation

FDA approves neoadjuvant/ adjuvant pembrolizumab for resectable non-small cell lung cancer

On October 16, 2023, the Food and Drug Administration approved pembrolizumab (Keytruda, Merck) with platinum-containing chemotherapy as neoadjuvant treatment, and with continuation of single-agent pembrolizumab as post-surgical adjuvant treatment for resectable (tumors ≥4 cm or node positive) non-small cell lung cancer (NSCLC).

More Information: https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-neoadjuvant-adjuvant-pembrolizumab-resectable-non-small-cell-lung-cancer

FDA approves nivolumab for adjuvant treatment of Stage IIB/C melanoma

On October 13, 2023, the Food and Drug Administration approved nivolumab (Opdivo, Bristol-Myers Squibb Company) for the adjuvant treatment of completely resected Stage IIB/C melanoma in patients 12 years and older.

More Information: https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-nivolumab-adjuvant-treatment-stage-iibc-melanoma

FDA approves encorafenib with binimetinib for metastatic non-small cell lung cancer with a BRAF V600E mutation

On October 11, 2023, the Food and Drug Administration approved encorafenib (Braftovi, Array BioPharma Inc., a wholly owned subsidiary of Pfizer) with binimetinib (Mektovi, Array BioPharma Inc.) for adult patients with metastatic non-small cell lung cancer (NSCLC) with a BRAF V600E mutation, as detected by an FDA-approved test.

FDA also approved the FoundationOne CDx (tissue) and FoundationOne Liquid CDx (plasma) as companion diagnostics for encorafenib with binimetinib. If no mutation is detected in a plasma specimen, the tumor tissue should be tested.

More Information: https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-encorafenib-binimetinib-metastatic-non-small-cell-lung-cancer-braf-v600e-mutation

FDA approves bosutinib for pediatric patients with chronic myelogenous leukemia

On September 26, 2023, the Food and Drug Administration approved bosutinib (Bosulif, Pfizer) for pediatric patients 1 year of age and older with chronic phase (CP) Ph+ chronic myelogenous leukemia (CML) that is newly diagnosed (ND) or resistant or intolerant (R/I) to prior therapy. The FDA also approved a new capsule dosage form available in strengths of 50 mg and 100 mg.

More Information: https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-bosutinib-pediatric-patients-chronic-myelogenous-leukemia

FDA approves new and updated indications for temozolomide under Project Renewal

On September 14, 2023, the Food and Drug Administration (FDA) approved updated labeling for temozolomide (Temodar, Merck) under Project Renewal, an Oncology Center of Excellence (OCE) initiative aimed at updating labeling information for older oncology drugs to ensure information is clinically meaningful and scientifically up-to-date. This is the second drug to receive a labeling update under this pilot program. The first drug that received approval under Project Renewal was capecitabine (Xeloda).

More Information: https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-new-and-updated-indications-temozolomide-under-project-renewal

FDA approves melphalan as a liver-directed treatment for uveal melanoma

On August 14, 2023, the Food and Drug Administration approved HEPZATO KIT (melphalan for Injection/Hepatic Delivery System) containing melphalan (HEPZATO, Delcath Systems, Inc.) as a liver-directed treatment for adult patients with uveal melanoma with unresectable hepatic metastases affecting less than 50% of the liver and no extrahepatic disease, or extrahepatic disease limited to the bone, lymph nodes, subcutaneous tissues, or lung that is amenable to resection or radiation.

More Information: https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-melphalan-liver-directed-treatment-uveal-melanoma

FDA grants accelerated approval to elranatamab-bcmm for multiple myeloma

On August 14, 2023, the Food and Drug Administration granted accelerated approval to elranatamab-bcmm (Elrexfio, Pfizer, Inc.), a bispecific B-cell maturation antigen (BCMA)-directed CD3 T-cell engager, for adults with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.

More Information: https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-elranatamab-bcmm-multiple-myeloma

FDA approves niraparib and abiraterone acetate plus prednisone for BRCA-mutated metastatic castration-resistant prostate cancer

On August 11, 2023, the Food and Drug Administration approved the fixed dose combination of niraparib and abiraterone acetate (Akeega, Janssen Biotech, Inc.), with prednisone, for adult patients with deleterious or suspected deleterious BRCA-mutated castration-resistant prostate cancer (mCRPC), as determined by an FDA-approved test.

More Information: https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-niraparib-and-abiraterone-acetate-plus-prednisone-brca-mutated-metastatic-castration

FDA grants accelerated approval to talquetamab-tgvs for relapsed or refractory multiple myeloma 

On August 9, 2023, the Food and Drug Administration granted accelerated approval to talquetamab-tgvs (Talvey, Janssen Biotech, Inc.) adults with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.

More Information: https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-talquetamab-tgvs-relapsed-or-refractory-multiple-myeloma

FDA approves pralsetinib for non-small cell lung cancer with RET gene fusions

On August 9, 2023, the Food and Drug Administration granted regular approval to pralsetinib (Gavreto, Genentech, Inc.) for adult patients with metastatic rearranged during transfection (RET) fusion-positive non-small cell lung cancer (NSCLC) as detected by an FDA-approved test.

More Information: https://www.fda.gov/drugs/drug-approvals-and-databases/fda-approves-pralsetinib-non-small-cell-lung-cancer-ret-gene-fusions

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