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(FDA) Approved Abecma tools Approved Drugs first-line treatment of patients with relapsed or refractory multiple myeloma locally advanced unresectable or who have received one to three prior metastatic human epidermal growth On Mar. 26, the U.S. Food and Drug lines of therapy. • factor receptor 2-positive gastric or Administration (FDA) approved gastroesophageal junction (GEJ) • On Apr. 7, the FDA granted regular ® ® Abecma (idecabtagene vicleucel) adenocarcinoma. approval to Trodelvy (sacituzumab (Bristol Myers Squibb and bluebird bio, govitecan-hziy) (Gilead, gilead.com) for bms.com and bluebirdbio.com) for the • On May 28, the FDA granted accelerated patients with unresectable locally approval to Lumakras™ treatment of adult patients with advanced or metastatic triple-negative (sotorasib) (Amgen, amgen.com) for relapsed or refractory multiple myeloma breast cancer who have received two or after four or more prior lines of therapy, adult patients with KRAS G12C mutated locally advanced or metastatic non- more prior systemic therapies, at least including an immunomodulatory one of them for metastatic disease. On agent, a proteasome inhibitor, and an small cell lung cancer (NSCLC), as Apr. 13, the FDA granted accelerated anti-CD38 monoclonal antibody. determined by an FDA-approved test, who have received at least one prior approval to Trodelvy for use in adult • On Apr. 6, the FDA approved a new systemic therapy. patients with locally advanced or dosage regimen of 500 mg/m2 as a metastatic urothelial cancer who have On Apr. 16, the FDA approved Opdivo® 120-minute intravenous infusion every • previously received a platinum- ® (nivolumab) (Bristol Myers Squibb, bms. two weeks for Erbitux (cetuximab) containing chemotherapy and either a (Eli Lilly, lilly.com) for patients with K-Ras com) in combination with certain types of chemotherapy for the initial programmed death receptor-1 or a wild-type, epidermal growth factor treatment of patients with advanced or programmed death-ligand 1 inhibitor. receptor (EGFR)-expressing colorectal metastatic gastric cancer, GEJ cancer, cancer or squamous cell carcinoma of • On May 28, the FDA granted accelerated and esophageal adenocarcinoma. On the head and neck. approval to Truseltiq (infigratinib)(QED May 20, the FDA approved Opdivo for Therapeutics, Inc., qedtx.com) for adults patients with completely resected • On Apr. 22, the FDA granted accelerated with previously treated, unresectable esophageal or GEJ cancer with residual approval to Jemperli (dostarlimab- locally advanced or metastatic cholan- gxly) (GlaxoSmithKline, pathologic disease who have received giocarcinoma with a fibroblast growth us.gsk.com/en-us) for patients with neoadjuvant chemoradiotherapy. factor receptor 2 fusion or other recurrent or advanced endometrial • On May 21, the FDA approved rearrangement as detected by an cancer that has progressed on or ™ Rybrevant (amivantamab-vmjw) (The FDA-approved test. following prior treatment with a Janssen Pharmaceutical Companies of platinum-containing chemotherapy Johnson & Johnson, janssen.com) for • Jazz Pharmaceuticals (jazzpharma.com) and whose cancers have a specific adult patients with NSCLC whose announced that the FDA approved genetic feature known as dMMR, as tumors have specific types of genetic a revised label for Vyxeos® determined by an FDA-approved test. mutations: EGFR exon 20 insertion (daunorubicin and cytarabine) to • On May 5, the FDA granted mutations. include a new indication to treat newly accelerated approval to Keytruda® • On Mar. 31, the FDA approved Sarclisa® diagnosed therapy-related acute (pembrolizumab) (Merck, merck.com) (isatuximab-irfc) (Sanofi Genzyme, myeloid leukemia or acute myeloid in combination with trastuzumab and sanofi.com/en) in combination with leukemia with myelodysplasia-related fluoropyrimidine- and platinum- carfilzomib and dexamethasone for the changes in pediatric patients aged one containing chemotherapy for the treatment of adult patients with year and older. 10 accc-cancer.org | Vol. 36, No. 4, 2021 | OI • On Apr. 23, ACD Therapeutics at least 10 percent of tumor cells • Takeda Pharmaceutical Company (ir.adctherapeutics.com) announced overexpressing FGFR2b. Limited (takeda.com) announced that FDA approval of Zynlonta™ the FDA accepted an NDA and granted BeiGene, Ltd. (beigene.com) announced (loncastuximab tesirine-lpyl) for the • priority review to maribavir for the that the FDA accepted a supplemental treatment of adult patients with treatment of post-transplant new drug application (NDA) and relapsed or refractory large B-cell cytomegalovirus infection in those granted priority review to Brukinsa® lymphoma after two or more lines of that are refractory, with or without (zanubrutinib) for the treatment of systemic therapy, including diffuse resistance, in solid organ transplant or adult patients with marginal zone large B-cell lymphoma not otherwise hematopoietic cell transplant specified, diffuse large B-cell lymphoma lymphoma who have received at least recipients. arising from low grade lymphoma, and one prior anti-CD20-based therapy. Mustang Bio, Inc. (mustangbio.com) high-grade B-cell lymphoma. • • Foresee Pharmaceuticals announced that the FDA accepted its • On May 13, Heron Therapeutics, Inc. (foreseepharma.com/en-us/index) investigational NDA for MB-106, a announced that the FDA approved the (herontx.com) announced that the FDA ® CD20-targeted chimeric antigen approved Zynrelef™ (bupivacaine and NDA for Camcevi (leuprolide) as a receptor T-cell therapy for relapsed or meloxicam) extended-release solution treatment for advanced prostate refractory CD20+ B-cell non-Hodgkin’s for use in adults for soft tissue or cancer. lymphoma and chronic lymphocytic periarticular instillation to produce • Legend Biotech Corporation leukemia. post-surgical analgesia for up to 72 (legendbiotech.com) announced that Takeda Pharmaceutical Company hours after bunionectomy, open • the FDA accepted for priority review the Limited (takeda.com) announced that inguinal herniorrhaphy, and total knee BLA submitted by the Janssen that the FDA granted priority review to arthroplasty. Pharmaceutical Companies of Johnson the NDA for mobocertinib (TAK-788) & Johnson (janssen.com) for for the treatment of adult patients with Drugs in the News ciltacabtagene autoleucel (cilta-cel), epidermal growth factor receptor an investigational B-cell maturation • AffyImmune Therapeutics, Inc. Exon20 insertion mutation-positive antigen-directed chimeric antigen (insertion+) metastatic NSCLC, as (affyimmune.com) announced that the receptor T-cell therapy. FDA granted fast track designation to detected by an FDA-approved test, who AIC100 for the treatment of anaplastic • Immutep Limited (immutep.com) have received prior platinum-based thyroid cancer and refractory poorly announced that it received FDA fast chemotherapy. differentiated thyroid cancer. track designation for eftilagimod alpha • Bristol Myers Squibb (bms.com) (IMP321) for first-line recurrent or • Agenus Inc. (agenusbio.com) announced that the FDA accepted the metastatic head and neck squamous supplemental BLA for Opdivo® announced the submission of a cell carcinoma. biologics license agreement (BLA) to (nivolumab) for the adjuvant treat- the FDA for the accelerated approval of • Taiho Oncology, Inc. (taihooncology. ment of patients with surgically balstilimab (AGEN2034) for the com) announced that the FDA granted resected, high-risk muscle-invasive treatment of patients with recurrent or breakthrough therapy designation for urothelial carcinoma. metastatic cervical cancer with disease futibatinib (TAS-120) for the treatment • Astellas Pharma Inc. (astellas.com) and progression on or after chemotherapy. of patients with previously treated Seagen Inc. (seagen.com) announced locally advanced or metastatic Amgen (amgen.com) announced that FDA acceptance and priority review for • cholangiocarcinoma harboring FGFR2 ® the FDA granted breakthrough therapy two supplemental BLAs for Padcev gene rearrangements, including gene (enfortumab vedotin-ejfv) in locally designation to bemarituzumab fusions. (anti-FGFR2b) as first-line treatment for advanced or metastatic urothelial patients with fibroblast growth factor • Merck (merck.com) and Eisai Inc. cancer. receptor 2b (FGFR2b) overexpressing (eisai.com/index.html) announced that • CTI BioPharma Corp. (ctibiopharma. and human epidermal growth factor the FDA has accepted and granted com) announced that it has completed receptor 2-negative metastatic and priority review for applications seeking a rolling NDA submission to the FDA locally advanced GEJ adenocarcinoma two new approvals for the combination seeking approval of pacritinib as a in combination with modified FOLFOX6 of Keytruda® (pembrolizumab) plus treatment for myelofibrosis in patients (fluoropyrimidine, leucovorin, and Lenvima® (lenvatinib) for the first-line with severe thrombocytopenia. The oxaliplatin), based on an FDA-approved treatment of patients with advanced NDA has been accepted by the FDA for companion diagnostic assay showing renal cell carcinoma. priority review. OI | Vol. 36, No. 4, 2021 | accc-cancer.org 11 • Fennec Pharmaceuticals Inc. treatment for patients with previously (amivantamab-vmjw) after progressing (fennecpharma.com) announced the treated IDH1-mutated on or after platinum-based chemother- resubmission of an NDA to the FDA for cholangiocarcinoma. apy. The test has also received FDA Pedmark™ (sodium thiosulfate) for the approval as a liquid biopsy companion • Seagen Inc. (seagen.com) and Genmab ™ prevention
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