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FDA Oncology Drug Approvals Granted Between May 21, 2018 and May 14, 2019


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Over the past year (May 2018–May 2019), the U.S. Food and Drug Administration (FDA) granted approval and accelerated approval to a number of new oncology drugs and biosimilars. Here we list the new FDA-approved labels and indications.

AVELUMAB (BAVENCIO) and AXITINIB (INLYTA) has been approved as a combination for first-line treatment for patients with advanced renal cell carcinoma. May 14, 2019.

RAMUCIRUMAB (CYRAMZA) as a single agent for hepatocellular carcinoma in patients who have an alpha fetoprotein level of ≥ 400 ng/mL and have been previously treated with sorafenib. May 10, 2019.

ADO-TRASTUZUMAB EMTANSINE (KADCYLA) has been approved for the adjuvant treatment of patients with HER2-positive early breast cancer, who have residual invasive disease after neoadjuvant taxane and trastuzumab-based treatment. May 3, 2019.

IVOSIDENIB (TIBSOVO) for newly diagnosed acute myeloid leukemia with a susceptible IDH1 mutation, as detected by an FDA-approved test, in patients who are at least 75 years old or who have comorbidities that preclude the use of intensive induction chemotherapy. May 2, 2019.

PEMBROLIZUMAB (KEYTRUDA) has been approved, plus axitinib, for the first-line treatment of patients with advanced renal cell carcinoma. April 19, 2019.

ERDAFITINIB (BALVERSA) has been granted accelerated approval for patients with locally advanced or metastatic urothelial carcinoma, with susceptible FGFR3 or FGFR2 genetic alterations, that has progressed during or following platinum-containing chemotherapy, including within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy. April 12, 2019.

PEMBROLIZUMAB (KEYTRUDA) has been approved for the first-line treatment of patients with stage III non–small cell lung cancer (NSCLC) who are not candidates for surgical resection or definitive chemoradiation or metastatic NSCLC. Patients’ tumors must have no epidermal growth factor receptor or anaplastic lymphoma kinase genomic aberrations and express programmed cell death ligand 1 (PD-L1; Tumor Proportion Score ≥ 1%), as determined by an FDA-approved test. April 11, 2019.

ATEZOLIZUMAB (TECENTRIQ) has been approved, in combination with carboplatin and etoposide, for the first-line treatment of adult patients with extensive-stage small cell lung cancer. March 18, 2019.

ATEZOLIZUMAB (TECENTRIQ) has been approved for PD-L1–positive, unresectable, locally advanced or metastatic triple-negative breast cancer. March 8, 2019.

TRASTUZUMAB and HYALURONIDASE-OYSK INJECTION (HERCEPTIN HYLECTA), a combination of trastuzumab, a HER2 receptor antagonist, and hyaluronidase, an endoglycosidase—for subcutaneous use for the treatment of HER2- overexpressing breast cancer. February 28, 2019.

TRIFLURIDINE/TIPIRACIL TABLETS (LONSURE), a fixed combination of trifluridine, a nucleoside metabolic inhibitor, and tipiracil—a thymidine phosphorylase inhibitor—for adult patients with metastatic gastric or gastroesophageal junction adenocarcinoma previously treated with at least two prior lines of chemotherapy that included a fluoropyrimidine, a platinum, either a taxane or irinotecan, and if appropriate, HER2- targeted therapy. February 22, 2019.

PEMBROLIZUMAB (KEYTRUDA) for the adjuvant treatment of patients with melanoma with the involvement of lymph nodes following complete resection. February 15, 2019.

CAPLACIZUMAB-YHDP (CABLIVI) for adult patients with acquired thrombotic thrombocytopenic purpura, in combination with plasma exchange and immunosuppressive therapy. February 6, 2019.

CABOZANTINIB (CABOMETYX) for patients with hepatocellular carcinoma who have been previously treated with sorafenib. January 14, 2019.

TAGRAXOFUSP-ERZS (ELZONRIS), a CD123-directed cytotoxin, for blastic plasmacytoid dendritic cell neoplasm in adults and in pediatric patients 2 years and older. December 21, 2018.

RAVULIZUMAB-CWVZ (ULTOMIRIS) for adult patients with paroxysmal nocturnal hemoglobinuria. December 21, 2018.

CALASPARGASE PEGOL-MKNL (ASPARLAS), an asparagine-specific enzyme, as a component of a multiagent chemotherapeutic regimen for acute lymphoblastic leukemia in pediatric and young adult patients, aged 1 month to 21 years. This new product provides for a longer interval between doses compared to other available pegaspargase products. December 20, 2018.

OLAPARIB (LYNPARZA) for the maintenance treatment of adult patients with deleterious or suspected deleterious germline or somatic BRCA-mutated advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy. December 19, 2018.

PEMBROLIZUMAB (KEYTRUDA) has been granted accelerated approval for adult and pediatric patients with recurrent, locally advanced or metastatic Merkel cell carcinoma. December 19, 2018.

TRASTUZUMAB-PKRB (HERZUMA) has been approved as a biosimilar to trastuzumab for patients with HER2-overexpressing breast cancer. December 14, 2018.

ROMIPLOSTIM (NPLATE) has been approved for pediatric patients who are 1 year of age and older, have had immune thrombocytopenia for at least 6 months, and who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy. December 14, 2018.

ATEZOLIZUMAB (TECENTRIQ) has been approved, in combination with bevacizumab, paclitaxel, and carboplatin, for the first-line treatment of patients with metastatic, nonsquamous, NSCLC with no epidermal growth factor receptor or anaplastic lymphoma kinase genomic tumor aberrations. December 6, 2018.

GILTERITINIB (XOSPATA) has been approved for the treatment of adult patients who have relapsed or refractory acute myeloid leukemia with a FLT3 mutation, as detected by an FDA-approved test. November 28, 2018.

RITUXIMAB-ABBS (TRUXIMA) has been approved as the first biosimilar to rituximab for patients with CD20-positive, B-cell non-Hodgkin lymphoma, to be used as a single agent or in combination with chemotherapy. November 28, 2018.

LAROTRECTINIB (VITRAKVI) has been granted accelerated approval for adult and pediatric patients with solid tumors that have a neurotrophic receptor tyrosine kinase gene fusion without a known acquired resistance mutation, that are either metastatic or where surgical resection is likely to result in severe morbidity, and who have no satisfactory alternative treatments, or whose cancer has progressed following treatment. November 26, 2018.

VENETOCLAX (VENCLEXTA) has been granted accelerated approval, in combination with azacitidine or decitabine or low-dose cytarabine, for the treatment of newly diagnosed acute myeloid leukemia in adults who are aged 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy. November 21, 2018.

GLASDEGIB (DAURISMO) has been approved, in combination with low-dose cytarabine, for newly diagnosed acute myeloid leukemia in patients who are 75 years old or older or who have comorbidities that preclude intensive induction chemotherapy. November 21, 2018.

EMAPALUMAB (GAMIFANT), a monoclonal antibody that binds and neutralizes interferon gamma for adult and pediatric patients, newborn and older, with primary hemophagocytic lymphohistiocytosis (HLH) with refractory, recurrent, or progressive disease, or intolerance with conventional HLH therapy. November 20, 2018.

BRENTUXIMAB VEDOTIN (ADCETRIS) has been approved, in combination with chemotherapy, for previously untreated systemic anaplastic large cell lymphoma or other CD30-expressing peripheral T-cell lymphomas. November 16, 2018.

PEMBROLIZUMAB (KEYTRUDA) has been approved for patients with hepatocellular carcinoma who have been previously treated with sorafenib. November 9, 2018.

LORLATINIB (LORBRENA) has been approved for patients with anaplastic lymphoma kinase (ALK)-positive, metastatic, NSCLC whose disease has progressed on crizotinib and at least one other ALK inhibitor for metastatic disease, or whose disease has progressed on alectinib or ceritinib as the first ALK inhibitor therapy for metastatic disease. November 2, 2018.

PEMBROLIZUMAB (KEYTRUDA) has been approved, in combination with carboplatin and either paclitaxel or nab-paclitaxel, as a first-line treatment for metastatic squamous NSCLC. October 30, 2018.

TALAZOPARIB (TALZENNA) has been approved for a poly (ADP-ribose) polymerase inhibitor for patients with deleterious or suspected deleterious germline BRCA-mutated, HER2-negative locally advanced or metastatic breast cancer. Patients must be selected for therapy based on an FDA-approved companion diagnostic for talazoparib. October 16, 2018.

EMICIZUMAB-KXWH INJECTION (HEMLIBRA) has been approved to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients aged newborn and older with hemophilia A, with or without factor VIII inhibitors. October 4, 2018.

CEMIPLIMAB-RWLC (LIBTAYO) has been approved for patients with metastatic cutaneous squamous cell carcinoma or locally advanced cutaneous squamous cell carcinoma who are not candidates for curative surgery or curative radiation. September 28, 2018.

DACOMITINIB TABLETS (VIZIMPRO) has been approved for the first-line treatment of patients with metastatic NSCLC with epidermal growth factor receptor exon 19 deletion or exon 21 L858R substitution mutations as detected by an FDA-approved test. September 27, 2018.

DUVELISIB (COPIKTRA) has been approved for adult patients with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma after at least two prior therapies. In addition, duvelisib received accelerated approval for adult patients with relapsed or refractory follicular lymphoma after at least two prior systemic therapies. September 24, 2018.

MOXETUMOMAB PASUDOTOX-TDFK (LUMOXITI), a CD22-directed cytotoxin indicated for adult patients with relapsed or refractory hairy cell leukemia who received at least two prior systemic therapies, including treatment with a purine nucleoside analog. September 13, 2018.

PEMBROLIZUMAB (KEYTRUDA) has been approved, in combination with pemetrexed and platinum, as first-line treatment of patients with metastatic, nonsquamous, NSCLC, with no EGFR or ALK genomic tumor aberrations. August 20, 2018.

PEMBROLIZUMAB (KEYTRUDA) and ATEZOLIZUMAB (TECENTRIQ) now has updated prescribing information that requires the use of an FDA-approved companion diagnostic test to determine the PD-L1 levels in tumor tissues from patients with locally advanced or metastatic urothelial cancer who are cisplatin-ineligible. The FDA has approved two different companion diagnostic tests, one for use with pembrolizumab and one for use with atezolizumab. August 16, 2018.

NIVOLUMAB (OPDIVO) has been granted accelerated approval for patients with metastatic small cell lung cancer with progression after platinum-based chemotherapy and at least one other line of therapy. August 16, 2018.

LENVATINIB CAPSULES (LENVIMA) for first-line treatment of patients with unresectable hepatocellular carcinoma. August 16, 2018.

MOGAMULIZUMAB-KPKC (POTELIGEO) for adult patients with relapsed or refractory mycosis fungoides or Sézary syndrome after at least one prior systemic therapy. August 8, 2018.

LUSUTROMBOPAG (MULPLETA) for thrombocytopenia in adults with chronic liver disease who are scheduled to undergo a medical or dental procedure. July 31, 2018.

IOBENGUANE I 131 (AZEDRA) for adult and pediatric patients 12 years and older with iobenguane scan–positive, unresectable, locally advanced or metastatic pheochromocytoma or paraganglioma who require systemic anticancer therapy. July 30, 2018.

IVOSIDENIB (TIBSOVO) was approved for adult patients with relapsed or refractory acute myeloid leukemia with a susceptible IDH1 mutation as detected by an FDA-approved test. July 20, 2018.

RIBOCICLIB (KISQALI) has expanded its indication, in combination with an aromatase inhibitor, for pre- and perimenopausal women with hormone receptor–positive, HER2-negative, advanced or metastatic breast cancer, as initial endocrine-based therapy. July 18, 2018.

ENZALUTAMIDE (XTANDI) was approved for patients with castration-resistant prostate cancer. July 13, 2018.

IPILIMUMAB (YERVOY) has been granted accelerated approval for use in combination with nivolumab for the treatment of patients 12 years of age and older, with microsatellite instability-high or mismatch repair–deficient metastatic colorectal cancer that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan. July 10, 2018.

ENCORAFENIB (BRAFTOVI) and BINIMETINIB (MEKTOVI) are approved, in combination, for patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, as detected by an FDA-approved test. June 27, 2018.

ATEZOLIZUMAB (TECENTRIQ) and PEMBROLIZUMAB (KEYTRUDA) have been limited in their use for patients with locally advanced or metastatic urothelial cancer who are not eligible for cisplatin-containing therapy. June 19, 2018.

PEMBROLIZUMAB (KEYTRUDA) for the treatment of adult and pediatric patients with refractory primary mediastinal large B-cell lymphoma, or who have relapsed after two or more prior lines of therapy. June 13, 2018.

BEVACIZUMAB (AVASTIN) is approved for patients with epithelial ovarian, fallopian tube, or primary peritoneal cancer in combination with carboplatin and paclitaxel, followed by single-agent bevacizumab, for stage III or IV disease after initial surgical resection. June 13, 2018.

PEMBROLIZUMAB (KEYTRUDA) is approved 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. June 12, 2018.

VENETOCLAX (VENCLEXTA) for patients with chronic lymphocytic leukemia or small lymphocytic lymphoma, with or without 17p depletion, who have received at least one prior therapy. June 8, 2018.

METHOXY POLYETHYLENE GLYCOL-EPOETIN BETA (MIRCERA) is approved for pediatric patients 5 to 17 years of age who are on hemodialysis who are converting from another erythropoietin-stimulating agent after their hemoglobin level was stabilized with an erythropoietin-stimulating agent. June 7, 2018.

PEGFILGRASTIM-JMDB (FULPHILA) is approved for use as a biosimilar to standard pegfilgrastim for use in decreasing the chance of infection in patients with nonmyeloid cancer who are receiving myelosuppressive chemotherapy that has a clinically significant incidence of febrile neutropenia. June 4, 2018.

AVATROMBOPAG (DOPTELET) received approval from the FDA for thrombocytopenia in adults with chronic liver disease who are scheduled to undergo a procedure. May 21, 2018. 


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