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New FDA-Approved Oncology Drugs and Label Updates Between May 8, 2020, and May 8, 2021


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Over the past year (May 2020–May 2021), the U.S. Food and Drug Administration (FDA) approved and expanded indications for many drugs related to the treatment of different types of cancers and adverse events. The new approvals and accelerated approvals are listed below.

PEMBROLIZUMAB (KEYTRUDA) in combination with trastuzumab 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. May 5, 2021.

LONCASTUXIMAB TESIRINE-LPYL (ZYNLONTA) was granted accelerated approval for adult patients 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. April 23, 2021.

DOSTARLIMAB-GXLY (JEMPERLI) was granted accelerated approval for adult patients with mismatch repair–deficient recurrent or advanced endometrial cancer, as determined by an FDA-approved test, that has progressed on or following a priorplatinum-containing regimen. April 22, 2021.

NIVOLUMAB (OPDIVO) was approved in combination with fluoropyrimidine- and platinum-containing chemotherapy for advanced or metastatic gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma. April 16, 2021.

SACITUZUMAB GOVITECAN-HZIY (TRODELVY) was granted accelerated approval for for advanced urothelial cancer. April 13, 2021.

SACITUZUMAB GOVITECAN-HZIY (TRODELVY) received regular approval 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. April 7, 2021.

ISATUXIMAB-IRFC (SARCLISA) was approved in combination with carfilzomib and dexamethasone, for the treatment of adult patients with relapsed or refractory multiple myeloma who have received one to three prior lines of therapy. March 31, 2021.

IDECABTAGENE VICLEUCEL (ABECMA) was approved for adult patients 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. This is the first FDA-approved cell-based gene therapy for multiple myeloma. March 26, 2021.

PEMBROLIZUMAB (KEYTRUDA) was approved in combination with platinum and fluoropyrimidine-based chemotherapy for patients with metastatic or locally advanced esophageal or gastroesophageal junction carcinoma who are not candidates for surgical resection or definitive chemoradiation. March 22, 2021.

TIVOZANIB (FOTIVDA) was approved for adults with relapsed or refractory advanced renal cell carcinoma following two or more prior systemic therapies. March 10, 2021.

AXICABTAGENE CILOLEUCEL (YESCARTA) was granted accelerated approval for adults with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy. March 5, 2021.

LORLATINIB (LORBRENA) was granted regular approval for patients with metastatic non–small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK)-positive, as detected by an FDA-approved test. The FDA also approved the Ventana ALK (D5F3) CDx Assay as a companion diagnostic for lorlatinib. March 3, 2021.

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 [TPS] > 50%), as determined by an FDA-approved test, with no epidermal growth factor receptor (EGFR), ALK, or ROS1 aberrations. February 22, 2021.

TRILACICLIB (COSELA) was granted approval 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 (SCLC). February 12, 2021.

CEMIPLIMAB-RWLC (LIBTAYO) was granted regular approval for patients with locally advanced basal cell carcinoma (BCC) previously treated with a Hedgehog pathway inhibitor (HHI) or for whom an HHI is not appropriate. The FDA also granted accelerated approval to cemiplimab for patients with metastatic BCC previously treated with an HHI or for whom an HHI is not appropriate. February 9, 2021.

UMBRALISIB (UKONIQ) was granted accelerated for 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. February 5, 2021.

LISOCABTAGENE MARALEUCEL (BREYANZI) was granted approval 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, high-grade B-cell lymphoma, primary mediastinal large B-cell lymphoma, and follicular lymphoma grade 3B. February 5, 2021.

TEPOTINIB (TEPMETKO) was granted accelerated approval for adults with metastatic NSCLC harboring mesenchymal-epithelial transition (MET) exon 14–skipping alterations. February 3, 2021.

RELUGOLIX (ORGOVYX) was approved for adults with advanced prostate cancer. January 25, 2021.

NIVOLUMAB (OPDIVO) in combination with cabozantinib (Cabometyx) was approved as first-line treatment for patients with advanced renal cell carcinoma. January 22, 2021.

DARATUMUMAB PLUS HYALURONIDASE--FIHJ (DARZALEX FASPRO) in combination with bortezomib, cyclophosphamide, and dexamethasone was granted accelerated approval for newly diagnosed light chain amyloidosis. January 15, 2021.

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. January 14, 2020.

SELINEXOR (XPOVIO) in combination with bortezomib (Velcade) and dexamethasone was approved for adults with multiple myeloma who have received at least one prior therapy. December 18, 2020.

RITUXIMAB-ARRX (RIABNI), a biosimilar to rituximab (Rituxan), was approved for adult patients with non-Hodgkin lymphoma, chronic lymphocytic leukemia, granulomatosis with polyangiitis (Wegener’s granulomatosis), and microscopic polyangiitis. December 17, 2020.

MARGETUXIMAB-CMKB (MARGENZA) in combination with chemotherapy was approved for adults with metastatic HER2-positive breast cancer who have received two or more prior anti-HER2 regimens, at least one of which was for metastatic disease. December 16, 2020.

GALLIUM-68 PSMA-11—the first drug for positron-emission tomography imaging of prostate-specific membrane antigen (PSMA)-positive lesions in men with prostate cancer—was approved. December 1, 2020.

THE FOUNDATIONONE LIQUID CDX TEST was approved for three new companion diagnostic indications to help match patients who may benefit from treatment with specific FDA-approved targeted therapies. The new indications are for alpelisib (Piqray) in advanced or metastatic breast cancer; rucaparib (Rubraca) in advanced ovarian cancer; and alectinib (Alecensa) in ALK-positive metastatic NSCLC. The FDA also approved a label expansion for FoundationOne Liquid CDx to report additional select copy number alterations and genomic rearrangements. October 27, 2020.

THE FOUNDATIONONE CDX TEST was approved as a companion diagnostic to identify fusions in the neurotrophic receptor tyrosine kinase (NTRK) genes NTRK1, NTRK2, and NTRK3 in DNA isolated from tumor tissue specimens from patients with solid tumors eligible for treatment with larotrectinib (Vitrakvi). October 23, 2020.

REMDESIVIR (VEKLURY) was approved for adult and pediatric patients 12 years of age and older and weighing at least 40 kg for the treatment of COVID-19 requiring -hospitalization. October 22, 2020.

VENETOCLAX (VENCLEXTA) in combination with azacitidine, decitabine, or low-dose cytarabine was granted regular approval for newly diagnosed acute myeloid leukemia (AML) in adults aged 75 or older or who have comorbidities precluding intensive induction chemotherapy. October 16, 2020.

PEMBROLIZUMAB (KEYTRUDA) received extended approval for adults with relapsed or refractory classical Hodgkin lymphoma and pediatric patients with refractory classical Hodgkin lymphoma or classical Hodgkin lymphoma that has relapsed after two or more lines of therapy. October 14, 2020.

NIVOLUMAB (OPDIVO) in combination with ipilimumab (Yervoy) was approved as first-line treatment for adults with unresectable malignant pleural mesothelioma. October 2, 2020.

AZACITIDINE (ONUREG) was approved for the continued treatment of adults with AML who achieved first complete remission or complete remission with incomplete blood cell count recovery following intensive induction chemotherapy and who are not able to complete intensive curative therapy. September 1, 2020.

DARATUMUMAB (DARZALEX) in combination with carfilzomib (Kyprolis) and dexamethasone was approved for adults with relapsed or refractory multiple myeloma who have received one to three previous lines of therapy. August 20, 2020.

BELANTAMAB MAFODOTIN-BLMF (BLENREP) was approved for adults with relapsed or refractory multiple myeloma who have received at least four prior therapies, including an anti-CD38 monoclonal antibody, a proteasome inhibitor, and an immunomodulatory agent. August 5, 2020.

ATEZOLIZUMAB (TECENTRIQ) plus the MEK inhibitor cobimetinib (Cotellic) and the selective BRAF kinase inhibitor vemurafenib (Zelboraf) was approved for patients with advanced BRAF V600 mutation–positive melanoma. July 30, 2020.

BREXUCABTAGENE AUTOLEUCEL (TECARTUS) was granted accelerated approval for adults with relapsed or refractory mantle cell lymphoma. July 24, 2020.

CEDAZURIDINE (INQOVI) and decitabine were approved for treatment of adults with myelodysplastic syndromes. July 7, 2020.

AVELUMAB (BAVENCIO) was approved for the maintenance treatment of patients with locally advanced or metastatic urothelial carcinoma that has not progressed with first-line platinum-containing chemotherapy. June 30, 2020.

PEMBROLIZUMAB (KEYTRUDA) was approved for the first-line treatment of patients with unresectable or metastatic microsatellite instability–high or mismatch repair–deficient colorectal cancer. June 29, 2020.

PERTUZUMAB in combination with trastuzumab and hyaluronidase-zzxf (Phesgo) was approved for use in combination with chemotherapy as neoadjuvant treatment of patients with HER2-positive, locally advanced, inflammatory, or early-stage breast cancer (either greater than 2 cm in diameter or node-positive) as part of a complete treatment regimen for early breast cancer and as adjuvant treatment of patients with HER2-positive early breast cancer at high risk of recurrence and for use in combination with docetaxel for treatment of patients with HER2-positive metastatic breast cancer who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease. June 29, 2020.

SELINEXOR (XPOVIO) was approved for adults with relapsed or refractory DLBCL not otherwise specified after at least two lines of systemic therapy. It was also approved for adults with DLBCL arising from follicular lymphoma. June 22, 2020.

TAZEMETOSTAT (TAZVERIK) was granted accelerated approval for adults with relapsed or refractory follicular lymphoma whose tumors are positive for an EZH2 mutation, as detected by an FDA-approved test, and who have received at least two prior systemic therapies, as well as for adults with relapsed or refractory follicular lymphoma who have no satisfactory alternative treatment options. The FDA also approved the cobas EZH2 Mutation Test as a companion diagnostic for tazemetostat. June 18, 2020.

GEMTUZUMAB OZOGAMICIN (MYLOTARG) received approval and extended the indication for newly diagnosed CD33-positive AML to include pediatric patients aged 1 month and older. June 16, 2020.

PEMBROLIZUMAB (KEYTRUDA) was granted accelerated approval for adult and pediatric patients with unresectable or metastatic tumor mutational burden–high (≥ 10 mutations/megabase) solid tumors, as determined by an FDA-approved test, that have progressed following prior treatment and who have no satisfactory alternative treatment options. The FDA also approved the FoundationOneCDx assay as a companion diagnostic for pembrolizumab. June 16, 2020.

LURBINECTEDIN (ZEPZELCA) received accelerated approval for adults with metastatic SCLC whose disease progressed on or after platinum-based chemotherapy. June 15, 2020.

PEGFILGRASTIM-APGF (NYVEPRIA), the biosimilar to pegfilgrastim (Neulasta), was approved to decrease the incidence of febrile neutropenia in patients with nonmyeloid malignancies receiving myelosuppressive anticancer drugs associated with a clinically significant incidence of febrile neutropenia. June 11, 2020.

NIVOLUMAB (OPDIVO) was approved for patients with unresectable advanced, recurrent, or metastatic esophageal squamous cell carcinoma after prior fluoropyrimidine- and platinum-based chemotherapy. June 10, 2020.

RAMUCIRUMAB (CYRAMZA) in combination with erlotinib was approved for the first-line treatment of metastatic NSCLC with EGFR exon 19 deletions or exon 21 (L858R) mutations. May 29, 2020.

ATEZOLIZUMAB (TECENTRIQ) in combination with bevacizumab (Avastin) was approved for the treatment of patients with unresectable or metastatic hepatocellular carcinoma who have not received prior systemic therapy. May 29, 2020.

NIVOLUMAB (OPDIVO) plus ipilimumab (Yervoy) and two cycles of platinum-doublet chemotherapy was approved as first-line treatment for patients with metastatic or recurrent NSCLC with no EGFR or ALK genomic tumor aberrations. May 26, 2020.

BRIGATINIB (ALUNBRIG) was approved for adults with ALK-positive metastatic NSCLC, as detected by an FDA-approved test. The FDA also approved the Vysis ALK Break Apart FISH Probe Kit as a companion diagnostic for brigatinib. May 22, 2020.

ATEZOLIZUMAB (TECENTRIQ) was approved for the first-line treatment of adults with metastatic NSCLC whose tumors have high PD-L1 expression, with no EGFR or ALK genomic tumor aberrations. The FDA also approved the Ventana PD-L1 (SP142) Assay as a companion diagnostic device for selecting patients with NSCLC for treatment with atezolizumab. May 18, 2020.

OLAPARIB (LYNPARZA) received an expanded indication to include its combination with bevacizumab for first-line maintenance treatment of adults with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy and whose cancer is associated with homologous recombination deficiency–positive status. The FDA also approved the Myriad myChoice CDx as a companion diagnostic for olaparib. May 8, 2020.

SELPERCATINIB (RETEVMO) was granted accelerated approval for adults with metastatic RET fusion–positive NSCLC, adult and pediatric patients 12 years of age and older with advanced or metastatic RET-mutant medullary thyroid cancer who require systemic therapy, and adult and pediatric patients 12 years of age or older with advanced or metastatic RET fusion–positive thyroid cancer who require systemic therapy and whose disease is refractory to treatment with radioactive iodine. May 8, 2020. 


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