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Approved Drugs • On September 28, the FDA approved • On August 16, the FDA approved the Libtayo® (cemiplimab-rwlc) (Sanofi, Dako PD-L1 IHC 22C3 PharmDx Assay • On September 24, the Food and Drug sanofi.com, and Regeneron, (Dako North America, Inc., agilent.com) Administration (FDA) approved regeneron.com) for the treatment of as a companion diagnostic to select Copiktra™ (duvelisib) (Verastem, Inc., patients with metastatic cutaneous patients with locally advanced or verastem.com) for the treatment of squamous cell carcinoma or locally metastatic urothelial carcinoma who adult patients with relapsed or advanced cutaneous squamous cell are cisplatin-ineligible for treatment refractory chronic lymphocytic carcinoma who are not candidates for with Keytruda.® leukemia/small lymphocytic curative surgery or curative radiation. Drugs in the News lymphoma after at least two prior On September 13, the FDA approved therapies. It also received accelerated • Lumoxiti™ (moxetumomab • Medsenic SAS (medsenic.com) approval for the treatment of adult pasudotox-tdfk) (AstraZeneca, announced that the FDA has granted patients with relapsed or refractory astrazeneca.com) for the treatment of orphan drug designation to Arscimed® follicular lymphoma after at least two adult patients with relapsed or (arsenic trioxide) for the treatment of prior systemic therapies. refractory hairy cell leukemia who have graft-versus-host disease. • On August 27, AbbVie Inc. (abbvie.com) received at least two prior systemic • Aslan Pharmaceuticals (aslanpharma.com) announced that the FDA approved therapies, including treatment with a ® announced that the FDA has granted Imbruvica (ibrutinib) plus rituximab purine nucleoside analog. orphan drug designation to ASLAN003 for the treatment of adult patients with • On August 17, Bristol-Myers Squibb for the treatment of acute myeloid Waldenström’s macroglobulinemia. Company (bms.com) announced that leukemia. ® • On August 17, the FDA approved the FDA has approved Opdivo Aravive Biologics, Inc. (aravive.com) ® • Keytruda (pembrolizumab) (Merck & (nivolumab) for patients with announced that the FDA has granted Co., Inc., merck.com) in combination metastatic small cell lung cancer fast track designation to AVB-S6-500 as with pemetrexed and platinum as whose cancer has progressed after a potential treatment for platinum- first-line treatment of patients with platinum-based chemotherapy and at resistant recurrent ovarian cancer. metastatic, nonsquamous non-small least one other line of therapy. cell lung cancer (NSCLC) with no • Cellectar Biosciences, Inc. (cellectar.com) • On September 27, the FDA approved announced that the FDA has granted epidermal growth factor receptor (EGFR) Vizimpro® (dacomitinib) (Pfizer Inc., or ALK genomic tumor aberrations. rare pediatric disease designation to pfizer.com) for the first-line treatment CLR 131 for the treatment of osteo • On August 16, the FDA approved of patients with metastatic NSCLC with sarcoma, a rare pediatric cancer. Lenvima® (lenvantinib) (Eisai Inc., EGFR exon 19 deletion or exon 21 L858R eisai.com) for first-line treatment of substitution mutations as detected by • Rafael Pharmaceuticals, Inc. patients with unresectable an FDA-approved test. (rafaelpharma.com) announced that the FDA has granted orphan drug hepatocellular carcinoma. Approval was Approved Devices based on an international, multicenter, designation to CPI-613 for the treat- ment of peripheral T-cell lymphoma. randomized, open-label, noninferiority • Roche (roche.com) announced that it trial conducted in 954 patients with has received approval from the FDA for • Janssen Pharmaceuticals (janssen.com) previously untreated, metastatic, or the cobas® EGFR Mutation Test v2 as a announced that a new drug application unresectable hepatocellular carcinoma. companion diagnostic test for Iressa.® (NDA) has been submitted to the FDA,
16 accc-cancer.org | November–December 2018 | OI seeking approval of erdafitinib for the who require systemic therapy and have Genetic Tests and Assays in the treatment of patients with locally progressed following platinum-based News advanced or metastatic urothelial chemotherapy and an anti-PD-1 or cancer and certain fibroblast growth anti-PD-L1 therapy and for the • On September 28, the FDA permitted factor receptor genetic alterations treatment of patients with RET-mutant marketing of the clonoSEQ® assay whose tumors have progressed after medullary thyroid cancer who require (Adaptive Biotechnologies, prior chemotherapy. systemic therapy, have progressed adaptivebiotech.com), a next- following prior treatment, and have no generation sequencing-based test for Bristol-Myers Squibb Company • acceptable alternative treatment minimal residual disease in patients (bms.com) announced that the FDA options. with ALL or multiple myeloma. accepted the company’s biologics license application (BLA) for Empliciti™ • Y-mAbs Therapeutics, Inc. (ymabs.com) • On August 8, PapGene, Inc. (elotuzumab) in combination with announced that the FDA has granted (papgeneinc.com) announced that it pomalidomide and low-dose breakthrough therapy designation to had received breakthrough device dexamethasone for the treatment of naxitamab, in combination with designation from the FDA for the patients with relapsed/refractory GM-CSF, for the treatment of high-risk PapGene test, a multi-analyte liquid multiple myeloma who have received neuroblastoma refractory to initial biopsy test that uses a combination of at least two prior therapies, including therapy or with incomplete response to circulating tumor DNA and protein lenalidomide and a proteasome salvage therapy in patients older than biomarkers to detect the presence of inhibitor. 12 months of age with persistent cancer in average-risk, asymptomatic refractory disease limited to bone individuals over the age of 65. Merck & Co., Inc. (merck.com) • marrow with or without evidence of announced that the FDA has accepted concurrent bone involvement. Devices in the News and granted priority review for a new supplemental BLA seeking accelerated • OBI Pharma, Inc. (obipharma.com) • Qiagen N.V. (qiagen.com) announced approval for Keytruda® announced that the FDA has granted that the FDA has approved a PMA (pembrolizumab) for the treatment of orphan drug designation for OBI-3424 Supplement, expanding the labeling adult and pediatric patients with for the treatment of acute claim of the therascreen® EGFR RGQ PCR recurrent locally advanced or lymphoblastic leukemia (ALL). Kit to allow its use as a companion metastatic Merkel cell carcinoma. diagnostic with Pfizer’s Vizimpro® for • Clovis Oncology, Inc. (clovisoncology. first-line treatment of patients with • Merck & Co., Inc. (merck.com) also com) announced that the FDA has NSCLC with EGFR exon 19 deletions or announced that the FDA has accepted granted breakthrough therapy an exon 21 L858R mutation. and granted priority review for a new designation to Rubraca® (rucaparib) as a supplemental BLA seeking approval for monotherapy treatment of adult Keytruda® (pembrolizumab) for patients with BRCA1/2-mutated FDA Expands Use of first-line treatment of locally advanced metastatic castration-resistant Gardasil®9 or metastatic nonsquamous or prostate cancer who have received at On October 5, the FDA approved a squamous NSCLC in patients whose least one prior androgen receptor- supplemental application for Gardasil9 tumors express PD-L1 (tumor directed therapy and taxane-based proportion score ≥1%) without EGFR or chemotherapy. (Human Papillomavirus 9-valent ALK genomic tumor aberrations. Vaccine, Recombinant) (Merck & • Karyopharm Therapeutics Inc. Co., Inc., merck.com), expanding the • Amgen (amgen.com) announced that (karyopharm.com) announced that the approved use of the vaccine to include the FDA has approved a supplemental FDA has accepted its NDA with priority NDA to expand the prescribing review seeking accelerated approval for individuals aged 27-45 years. information for Kyprolis® (carfilzomib) selinexor as a new treatment for to include a once-weekly dosing option patients with penta-refractory multiple in combination with dexamethasone myeloma. FDA Updates Prescribing for patients with relapsed or refractory Information for Keytruda® Bristol-Myers Squibb Company multiple myeloma. • (bms.com) announced that the FDA and Tecentriq® • Loxo Oncology, Inc. (loxooncology.com) accepted has its supplemental BLA for Prescribing Keytruda (pembrolizumab) announced that the FDA has granted Sprycel® (dasatinib) in combination (Merck & Co., Inc., merck.com) and breakthrough therapy designation to with chemotherapy for the treatment Tecentriq (atezolizumab) (Genentech, LOXO-292, a selective RET inhibitor, for of pediatric patients with newly Inc., gene.com) now requires the use of the treatment of patients with diagnosed Philadelphia an FDA-approved companion diagnos- metastatic, RET-fusion-positive NSCLC chromosome-positive ALL. tic test to determine PD-L1 levels in tumor tissue from patients with locally advanced or metastatic urothelial cancer who are cisplatin-ineligible. .
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