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 epcoritamab-bysp for relapsed or refractory diffuse large B-cell lymphoma and high-grade B-cell lymphoma

On May 19, 2023, the Food and Drug Administration granted accelerated approval to epcoritamab-bysp (Epkinly, Genmab US, Inc.) for relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from indolent lymphoma, and high-grade B-cell lymphoma after two or more lines of systemic therapy.

More Information: https://www.fda.gov/drugs/drug-approvals-and-databases/fda-grants-accelerated-approval-epcoritamab-bysp-relapsed-or-refractory-diffuse-large-b-cell

FDA approves polatuzumab vedotin-piiq for previously untreated diffuse large B-cell lymphoma, not otherwise specified, and high-grade B-cell lymphoma

On April 19, 2023, the Food and Drug Administration approved polatuzumab vedotin-piiq (Polivy, Genentech, Inc.) with a rituximab product, cyclophosphamide, doxorubicin, and prednisone (R-CHP) for adult patients who have previously untreated diffuse large B-cell lymphoma (DLBCL), not otherwise specified (NOS), or high-grade B-cell lymphoma (HGBL) and who have an International Prognostic Index (IPI) score of 2 or greater.

More information: https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-polatuzumab-vedotin-piiq-previously-untreated-diffuse-large-b-cell-lymphoma-not

FDA approves omidubicel to reduce time to neutrophil recovery and infection in patients with hematologic malignancies

On April 17, 2023, the Food and Drug Administration approved omidubicel-onlv (Omisirge, Gamida Cell Ltd.) for use in adult and pediatric patients (12 years and older) with hematologic malignancies who are planned for umbilical cord blood transplantation following myeloablative conditioning to reduce the time to neutrophil recovery and the incidence of infection.

More Information: https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-omidubicel-reduce-time-neutrophil-recovery-and-infection-patients-hematologic

FDA grants accelerated approval to enfortumab vedotin-ejfv with pembrolizumab for locally advanced or metastatic urothelial carcinoma 

On April 3, 2023, the Food and Drug Administration granted accelerated approval to enfortumab vedotin-ejfv (Padcev, Astellas Pharma) with pembrolizumab (Keytruda, Merck) for patients with locally advanced or metastatic urothelial carcinoma who are ineligible for cisplatin-containing chemotherapy.

More Information: https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-enfortumab-vedotin-ejfv-pembrolizumab-locally-advanced-or-metastatic

FDA grants accelerated approval to retifanlimab-dlwr for metastatic or recurrent locally advanced Merkel cell carcinoma

On March 22, 2023, the Food and Drug Administration granted accelerated approval to retifanlimab-dlwr (Zynyz, Incyte Corporation) for adult patients with metastatic or recurrent locally advanced Merkel cell carcinoma (MCC).

More Information:  https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-retifanlimab-dlwr-metastatic-or-recurrent-locally-advanced-merkel

FDA approves dabrafenib with trametinib for pediatric patients with low-grade glioma with a BRAF V600E mutation

On March 16, 2023, the Food and Drug Administration approved dabrafenib (Tafinlar, Novartis) with trametinib (Mekinist, Novartis) for pediatric patients 1 year of age and older with low-grade glioma (LGG) with a BRAF V600E mutation who require systemic therapy. The FDA also approved new oral formulations of both drugs suitable for patients who cannot swallow pills.

More Information: https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-dabrafenib-trametinib-pediatric-patients-low-grade-glioma-braf-v600e-mutation

FDA expands early breast cancer indication for abemaciclib with endocrine therapy

On March 3, 2023, the Food and Drug Administration (FDA) approved abemaciclib (Verzenio, Eli Lilly and Company) with endocrine therapy (tamoxifen or an aromatase inhibitor) for the adjuvant treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, node-positive, early breast cancer at high risk of recurrence.

More Information: https://www.fda.gov/drugs/resources-information-approved-drugs/fda-expands-early-breast-cancer-indication-abemaciclib-endocrine-therapy

FDA grants regular approval to dostarlimab-gxly for dMMR endometrial cancer

On February 9, 2023, the Food and Drug Administration (FDA) approved dostarlimab-gxly (Jemperli, GlaxoSmithKline LLC) for adult patients with mismatch repair deficient (dMMR) recurrent or advanced endometrial cancer, as determined by an FDA-approved test, that has progressed on or following a prior platinum-containing regimen in any setting and are not candidates for curative surgery or radiation.

More Information: https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-regular-approval-dostarlimab-gxly-dmmr-endometrial-cancer

FDA approves sacituzumab govitecan-hziy for HR-positive breast cancer

On February 3, 2023, the Food and Drug Administration (FDA) approved sacituzumab govitecan-hziy (Trodelvy, Gilead Sciences, Inc.) for unresectable locally advanced or metastatic hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer who have received endocrine-based therapy and at least two additional systemic therapies in the metastatic setting.

More Information: https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-sacituzumab-govitecan-hziy-hr-positive-breast-cancer

FDA grants accelerated approval to pirtobrutinib for relapsed or refractory mantle cell lymphoma

On January 27, 2023, the Food and Drug Administration (FDA) granted accelerated approval to pirtobrutinib (Jaypirca, Eli Lilly and Company) for relapsed or refractory mantle cell lymphoma (MCL) after at least two lines of systemic therapy, including a BTK inhibitor.

More Information: https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-pirtobrutinib-relapsed-or-refractory-mantle-cell-lymphoma

FDA approves elacestrant for ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer

On January 27, 2023, the Food and Drug Administration (FDA) approved elacestrant (Orserdu, Stemline Therapeutics, Inc.) for postmenopausal women or adult men with ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer with disease progression following at least one line of endocrine therapy.

More Information: https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-elacestrant-er-positive-her2-negative-esr1-mutated-advanced-or-metastatic-breast-cancer

FDA approves pembrolizumab as adjuvant treatment for non-small cell lung cancer 

On January 26, 2023, the Food and Drug Administration (FDA) approved pembrolizumab (Keytruda, Merck) for adjuvant treatment following resection and platinum-based chemotherapy for stage IB (T2a ≥4 cm), II, or IIIA non-small cell lung cancer (NSCLC).

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

FDA grants accelerated approval to tucatinib with trastuzumab for colorectal cancer

On January 19, 2023, the Food and Drug Administration (FDA) granted accelerated approval to tucatinib (Tukysa, Seagen Inc.) in combination with trastuzumab for RAS wild-type HER2-positive unresectable or metastatic colorectal cancer that has progressed following fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy.

More Information:  https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-tucatinib-trastuzumab-colorectal-cancer

FDA approves zanubrutinib for chronic lymphocytic leukemia or small lymphocytic lymphoma

On January 19, 2023, the Food and Drug Administration (FDA) approved zanubrutinib (Brukinsa, BeiGene USA, Inc.) for chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).

More Information:  https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-zanubrutinib-chronic-lymphocytic-leukemia-or-small-lymphocytic-lymphoma

FDA approves first adenoviral vector-based gene therapy for high-risk Bacillus Calmette-Guérin unresponsive non-muscle invasive bladder cancer 

On December 16, 2022, the Food and Drug Administration approved nadofaragene firadenovec-vncg (Adstiladrin, Ferring Pharmaceuticals) for adult patients with high-risk Bacillus Calmette-Guérin (BCG) unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors.

More Information:  https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-first-adenoviral-vector-based-gene-therapy-high-risk-bacillus-calmette-guerin

FDA approves updated drug labeling including new indications and dosing regimens for capecitabine tablets under Project Renewal

On December 14, 2022, the Food and Drug Administration approved updated labeling for capecitabine tablets (Xeloda, Genentech, Inc.) under Project Renewal, an Oncology Center of Excellence (OCE) initiative aimed at updating labeling information for certain older oncology drugs to ensure information is clinically meaningful and scientifically up to date.

More Information:  https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-updated-drug-labeling-including-new-indications-and-dosing-regimens-capecitabine

FDA grants accelerated approval to adagrasib for KRAS G12C-mutated NSCLC

On December 12, 2022, the Food and Drug Administration (FDA) granted accelerated approval to adagrasib (Krazati, Mirati Therapeutics, Inc.), a RAS GTPase family inhibitor, for adult patients with KRAS G12C¬-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC), as determined by an FDA-approved test, who have received at least one prior systemic therapy.

More Information: https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-adagrasib-kras-g12c-mutated-nsclc

FDA grants approval to atezolizumab for alveolar soft part sarcoma

On December 9, 2022, the Food and Drug Administration (FDA) approved atezolizumab (Tecentriq, Genentech, Inc.) for adult and pediatric patients 2 years of age and older with unresectable or metastatic alveolar soft part sarcoma (ASPS).

More Information:  https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-approval-atezolizumab-alveolar-soft-part-sarcoma

FDA approves olutasidenib for relapsed or refractory acute myeloid leukemia with a susceptible IDH1 mutation

On December 1, 2022, the Food and Drug Administration (FDA) approved olutasidenib (Rezlidhia) capsules for adult patients with relapsed or refractory acute myeloid leukemia (AML) with a susceptible IDH1 mutation as detected by an FDA-approved test.

More Information: https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-olutasidenib-relapsed-or-refractory-acute-myeloid-leukemia-susceptible-idh1-mutation

FDA approves a new dosing regimen for asparaginase erwinia chrysanthemi (recombinant) 

On November 18, 2022, the Food and Drug Administration approved a new Monday-Wednesday-Friday dosing regimen for asparaginase erwinia chrysanthemi (recombinant)-rywn (Rylaze, Jazz Pharmaceuticals). Under the new regimen, patients should receive 25 mg/m2 intramuscularly on Monday and Wednesday mornings, and 50 mg/m2 intramuscularly on Friday afternoon. It also is approved to be administered every 48 hours at a dose of 25 mg/m2 intramuscularly.

More Information:  https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-new-dosing-regimen-asparaginase-erwinia-chrysanthemi-recombinant

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