Over the past year, the U.S. Food and Drug Administration (FDA) granted approval to many novel drugs and new indications for older therapeutic agents used in oncology and hematology.
NOVEMBER
Pafolacianine for Ovarian Cancer Lesions: On November 29, pafolacianine (Cytalux), an imaging drug, received approval for use in adults with ovarian cancer to help identify cancerous lesions during surgery.
Sirolimus Protein-Bound Particles for Rare Sarcoma: On November 22, sirolimus protein-bound particles for injectable suspension (albumin-bound; Fyarro) was approved for treatment of adults with locally advanced unresectable or metastatic malignant perivascular epithelioid cell tumor.
Pembrolizumab for Adjuvant Treatment of Renal Cell Carcinoma: On November 17, pembrolizumab (Keytruda) was approved for the adjuvant treatment of patients with renal cell carcinoma at intermediate-high or high risk of disease recurrence following nephrectomy or nephrectomy and resection of metastatic lesions.
OCTOBER
Asciminib for Philadelphia Chromosome–Positive CML: On October 29, asciminib (Scemblix) received accelerated approval for the treatment of patients with Philadelphia chromosome–positive chronic myeloid leukemia (CML) in chronic phase, previously treated with two more tyrosine kinase inhibitors, and approved the agent for adults with Philadelphia chromosome–positive CML in chronic phase with the T315I mutation.
Atezolizumab as Adjuvant Treatment of NSCLC: On October 15, atezolizumab (Tecentriq) was approved for adjuvant treatment following resection and platinum-based chemotherapy in patients with stage II to IIIA non–small cell lung cancer (NSCLC) whose tumors have PD-L1 expression on ≥ 1% of tumor cells, as determined by an FDA-approved test.
Pembrolizumab Combination for Cervical Cancer: On October 13, pembrolizumab (Keytruda) in combination with chemotherapy, with or without bevacizumab (Avastin), was approved for patients with persistent, recurrent, or metastatic cervical cancer whose tumors express PD-L1 (combined positive score [CPS] ≥ 1), as determined by an FDA-approved test.
The FDA also granted regular approval to pembrolizumab as a single agent for patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy whose tumors express PD-L1 (CPS ≥ 1), as determined by an FDA-approved test.
Abemaciclib in Combination With Endocrine Therapy for Breast Cancer: On October 12, abemaciclib (Verzenio) in combination with endocrine therapy (tamoxifen or an aromatase inhibitor) was approved for the adjuvant treatment of adults with hormone receptor–positive, HER2-negative, node-positive early breast cancer who are at high risk of disease recurrence and who also have a Ki67 score ≥ 20%, as determined by an FDA-approved test.
Brexucabtagene Autoleucel for Relapsed or Refractory B-Cell Precursor ALL: On October 1, brexucabtagene autoleucel (Tecartus) received approval for adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).
SEPTEMBER
Cetuximab With Encorafenib in BRAF V600E Mutation–Positive Metastatic Colorectal Cancer: On September 28, cetuximab (Erbitux) was approved in combination with encorafenib (Braftovi) for the treatment of adults with metastatic colorectal cancer and a BRAF V600E mutation, as detected by an FDA-approved test, after prior therapy.
Ruxolitinib for Chronic GVHD: On September 22, ruxolitinib (Jakafi) was approved for the treatment of chronic graft-vs-host disease (GVHD) after failure of one or two lines of systemic therapy in adult and pediatric patients aged 12 years and older.
Tisotumab Vedotin-tftv for Recurrent or Metastatic Cervical Cancer: On September 20, tisotumab vedotin-tftv (Tivdak) was approved for treatment of adults with recurrent or metastatic cervical cancer who experienced disease progression on or after chemotherapy.
Cabozantinib for Previously Treated Radioactive Iodine–Refractory Differentiated Thyroid Cancer: On September 17, cabozantinib (Cabometyx) was approved for the treatment of adult and pediatric patients aged 12 years and older with locally advanced or metastatic differentiated thyroid cancer that has progressed following prior VEGFR-targeted therapy and who are radioactive iodine–refractory or ineligible.
Mobocertinib for Metastatic NSCLC and EGFR Exon 20 Insertion Mutations: On September 15, mobocertinib (Exkivity) was granted accelerated approval to treat adults with locally advanced or metastatic NSCLC and EGFR exon 20 insertion mutations (as detected by an FDA-approved test) whose disease has progressed on or after plantium-based chemotherapy.
Zanubrutinib in Relapsed or Refractory Marginal Zone Lymphoma: On September 15, zanubrutinib (Brukinsa) received accelerated approval for the treatment of adults with relapsed or refractory marginal zone lymphoma who have received at least one anti–CD20-based regimen.
AUGUST
Zanubrutinib for Waldenström’s Macroglobulinemia: On August 31, zanubrutinib (Brukinsa) was approved for the treatment of adults with Waldenström’s macroglobulinemia.
Ivosidenib for Advanced or Metastatic IDH1-Mutated Cholangiocarcinoma: On August 25, ivosidenib (Tibsovo) was granted approval for the treatment of adults with previously treated locally advanced or metastatic cholangiocarcinoma with a IDH1 mutation, as detected by an FDA-approved test.
Nivolumab for Adjuvant Treatment of Urothelial Carcinoma: On August 19, the anti–PD-1 therapy nivolumab (Opdivo) was approved for the adjuvant treatment of patients with urothelial carcinoma who are at high risk of disease recurrence after undergoing radical resection.
Dostarlimab-gxly for Advanced Solid Tumors: On August 17, accelerated approval was granted to dostarlimab-gxly (Jemperli), an anti–PD-1 antibody, for adults with mismatch repair–deficient (dMMR) recurrent or advanced solid tumors (as determined by an FDA-approved test) who have had disease progression on or following prior treatment and who have no satisfactory alternative treatment options.
Lenvatinib/Pembrolizumab for Advanced Renal Cell Carcinoma: On August 10, the the combination of lenvatinib (Lenvima) plus pembrolizumab (Keytruda) received approval for the first-line treatment of adults with advanced renal cell carcinoma.
JULY
Pembrolizumab for High-Risk, Early-Stage Triple-Negative Breast Cancer: On July 26, pembrolizumab (Keytruda) was approved for high-risk, early-stage triple-negative breast cancer in combination with chemotherapy as a neoadjuvant treatment and then continued as a single agent as adjuvant treatment after surgery.
Pembrolizumab/Lenvatinib for Advanced Endometrial Carcinoma: On July 21, pembrolizumab (Keytruda) in combination with lenvatinib (Lenvima) was granted approval for treatment of patients with advanced endometrial carcinoma that is not microsatellite instability–high or dMMR.
Belumosudil for Chronic GVHD: On July 16, belumosudil (Rezurock) was approved for treatment of adult and pediatric patients aged 12 years and older with chronic GVHD after failure of at least two prior lines of systemic therapy.
Enfortumab Vedotin-ejfvor Locally Advanced or Metastatic Urothelial Cancer: On July 9, enfortumab vedotin-ejfv (Padcev) was approved for adults with locally advanced or metastatic urothelial cancer who have previously received a PD-1 or PD-L1 inhibitor and platinum-containing chemotherapy. It also was approved for patients who are ineligible for cisplatin-containing chemotherapy and have previously received one or more prior lines of therapy.
Daratumumab/Hyaluronidase-fihj With Pomalidomide/Dexamethasone in Multiple Myeloma: On July 9, daratumumab and hyaluronidase-fihj (Darzalex Faspro) in combination with pomalidomide and dexamethasone was approved for treatment of adults with multiple myeloma who have received at least one prior line of therapy including lenalidomide and a proteasome inhibitor.
JUNE
Asparaginase Erwinia Chrysanthemi (Recombinant)-rywn in ALL and Lymphoblastic Lymphoma: On June 30, asparaginase erwinia chrysanthemi (recombinant)-rywn (Rylaze) was approved for treatment of ALL and lymphoblastic lymphoma in patients who are allergic to Escherichi coli–derived asparaginase products, as a component of a chemotherapy regimen.
Avapritinib for Advanced Systematic Mastocytosis: On June 16, the tyrosine kinase inhibitor avapritinib (Ayvakit) was approved for treatment of adults with advanced systemic mastocytosis, including patients with aggressive systemic mastocytosis, systemic mastocytosis with an associated hematologic neoplasm, and mast cell leukemia.
MAY
Infigratinib for Cholangiocarcinoma With Fibroblast Growth Factor Receptor 2Fusion: On May 28, the kinase inhibitor infigratinib (Truseltiq) received accelerated approval for adults with previously treated, unresectable, locally advanced, or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 fusion or other rearrangement, as detected by an FDA-approved test.
Sotorasib for KRAS G12C–Mutated NSCLC: On May 28, sotorasib (Lumakras) was approved as the first treatment for adults with NSCLC whose tumors have a KRAS G12C genetic mutation and who have received at least one prior systemic therapy.
Piflufolastat F-18 Injection for Detection of Prostate Cancer: On May 27, piflufolastat F-18 injection (Pylarify) was approved for the identification of suspected metastasis or recurrence of prostate cancer.
Amivantamab-vmjw for Metastatic EGFR Exon 20 Insertion–Mutated NSCLC: On May 21, accelerated approval was granted to amivantamab-vmjw (Rybrevant) for adults with locally advanced or metastatic NSCLC and EGFR exon 20 insertion mutations (as detected by an FDA-approved test) whose disease has progressed on or after platinum-based chemotherapy.
Nivolumab for Esophageal or Gastroesophageal Junction Cancer: On May 20, nivolumab (Opdivo) was approved for patients with completely resected esophageal or gastroesophageal junction cancer with residual pathologic disease who have received neoadjuvant chemoradiotherapy.
Pembrolizumab Combination for HER2-Positive Gastric Cancer: On May 5, pembrolizumab (Keytruda) in combination with trastuzumab (Enhertu, Herceptin) plus fluoropyrimidine- and platinum-containing chemotherapy was approved for the first-line treatment of patients with locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma.
APRIL
Loncastuximab Tesirine-lpyl for Large B-Cell Lymphoma: On April 23, loncastuximab tesirine-lpyl (Zynlonta) was granted accelerated approval to for adults with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, DLBCL arising from low-grade lymphoma, and high-grade B-cell lymphoma.
Dostarlimab-gxly for Endometrial Cancer: On April 22, dostarlimab-gxly (Jemperli) was approved for the treatment of endometrial cancer.
Nivolumab Combination for Gastric Cancer: On April 16, nivolumab (Opdivo) in combination with fluoropyrimidine- and platinum-containing chemotherapy was approved for advanced or metastatic gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma.
Sacituzumab Govitecan-hziy for Metastatic Urothelial Cancer: On April 13, sacituzumab govitecan-hziy (Trodelvy) received accelerated approval for patients with locally advanced or metastatic urothelial cancer who previously received a platinum-containing chemotherapy and either a PD-1 or PD-L1 inhibitor.
Sacituzumab Govitecan-hziy for Breast Cancer: On April 7, sacituzumab govitecan-hziy (Trodelvy) was approved for patients with unresectable locally advanced or metastatic triple-negative breast cancer who have received two or more prior systemic therapies, at least one of them for metastatic disease.
New Dosage Regimen for Cetuximab in Colorectal Cancer, Head and Neck Cancer: On April 6, approval was granted for a new dosage regimen for cetuximab (Erbitux) of 500 mg/m2 as a 120-minute intravenous infusion every 2 weeks for patients with KRAS wild-type, EGFR-expressing colorectal cancer, or squamous cell carcinoma of the head and neck.
MARCH
Isatuximab-irfc Combination for Multiple Myeloma: On March 31, isatuximab-irfc (Sarclisa) in combination with carfilzomib and dexamethasone was approved for the treatment of adults with relapsed or refractory multiple myeloma who have received one to three prior lines of therapy.
Idecabtagene Vicleucel for Multiple Myeloma: On March 26, idecabtagene vicleucel (Abecma) was approved for the treatment of adults with relapsed or refractory multiple myeloma after four or more prior lines of therapy, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody.
Pembrolizumab Combination for Advanced Esophageal or Gastroesophageal Junction Cancer: On March 22, pembrolizumab (Keytruda) in combination with platinum- and fluoropyrimidine-based chemotherapy was approved for patients with metastatic or locally advanced esophageal or gastroesophageal junction (tumors with epicenter 1–5 cm above the gastroesophageal junction) carcinoma who are not candidates for surgical resection or definitive chemoradiation.
Tivozanib for Advanced Renal Cell Carcinoma: On March 10, tivozanib (Fotivda), a kinase inhibitor, was approved for adults with relapsed or refractory advanced renal cell carcinoma following two or more prior systemic therapies.
Axicabtagene Ciloleucel for Follicular Lymphoma: On March 5, axicabtagene ciloleucel (Yescarta) received accelerated approval for adults with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy.
Lorlatinib for Metastatic ALK-Positive NSCLC: On March 3, lorlatinib (Lorbrena) was approved for patients with metastatic NSCLC whose tumors are ALK-positive, as detected by an FDA-approved test.
FEBRUARY
Melphalan Flufenamide for Multiple Myeloma: On February 26, melphalan flufenamide (Pepaxto) was approved for treatment of relapsed or refractory multiple myeloma.
Cemiplimab-rwlc for NSCLC: On February 22, cemiplimab-
rwlc (Libtayo) was approved for the first-line treatment of patients with advanced NSCLC whose tumors have high PD-L1 expression (tumor proportion score > 50%), as determined by an FDA-approved test, with no EGFR, ALK, or receptor tyrosine kinase (ROS1) aberrations.
Trilaciclib for Chemotherapy-Induced Bone Marrow Suppression: On February 12, trilaciclib (Cosela) was approved as the first therapy in its class to reduce the frequency of chemotherapy-induced bone marrow suppression in adults receiving certain types of chemotherapy for extensive-stage small cell lung cancer.
Cemiplimab-rwlc for Basal Cell Carcinoma: On February 9, cemiplimab-rwlc (Libtayo) was approved for patients with locally advanced basal cell carcinoma previously treated with a Hedgehog pathway inhibitor (HHI) or for whom an HHI is not appropriate. Accelerated approval was also granted to cemiplimab for patients with metastatic basal cell carcinoma previously treated with an HHI or for whom an HHI is not appropriate.
Umbralisib for Lymphoma: On February 5, umbralisib (Ukoniq) received accelerated approval for the treatment of adults with relapsed or refractory marginal zone lymphoma who have received at least one prior anti-CD20–based regimen and adults with relapsed or refractory follicular lymphoma who have received at least three prior lines of systemic therapy.
Lisocabtagene Maraleucel for Large B-Cell Lymphoma: On February 5, lisocabtagene maraleucel (Breyanzi) was approved for the treatment of adults with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including DLBCL not otherwise specified (including DLBCL arising from indolent lymphoma), high-grade B-cell lymphoma, primary mediastinal large B-cell lymphoma, and follicular lymphoma grade 3B.
Tepotinib for NSCLC: On February 3, tepotinib (Tepmetko) was granted accelerated approval for adults with metastatic NSCLC harboring MET exon 14–skipping alterations.
JANUARY
Relugolix for Prostate Cancer: On January 25, relugolix (Orgovyx) was approved for adults with advanced prostate cancer.
Nivolumab/Cabozantinib for Renal Cell Carcinoma: On January 22, nivolumab (Opdivo) in combination with cabozantinib (Cabometyx) was approved as first-line treatment for patients with advanced renal cell carcinoma.
Daratumumab Plus Hyaluronidase-fihj Combination for Light Chain Amyloidosis: On January 15, daratumumab plus hyaluronidase-fihj (Darzalex faspro) in combination with bortezomib, cyclophosphamide, and dexamethasone was granted accelerated approval for newly diagnosed light chain amyloidosis.
Crizotinib for Anaplastic Large Cell Lymphoma: On January 14, crizotinib (Xalkori) was approved for pediatric patients aged 1 year and older and young adults with relapsed or refractory systemic anaplastic large cell lymphoma that is ALK-positive.
