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Approved Drugs refractory classical Hodgkin’s • Rafael Pharmaceuticals, Inc. (rafael- or classical Hodgkin’s lymphoma that has pharma.com) announced today that FDA • On Nov. 25, Y-mAbs Therapeutics, Inc. relapsed after two or more lines of has granted fast track designation to (ymabs.com) announced that the U.S. therapy. CPI-613® (devimistat) for the treatment Food and Drug Administration (FDA) of metastatic pancreatic cancer. On Nov. 13, the FDA granted accelerated approved Danyelza® (-gqgk) • approval to Keytruda® () AstraZeneca (astrazeneca.com) and in combination with granulocyte- • (Merck, merck.com) in combination with Daiichi Sankyo’s (daiichisankyo.com) macrophage colony-stimulating factor for the treatment of Enhertu® ( deruxtecan) for the treatment of pediatric patients patients with locally recurrent unresect- received FDA acceptance of its supple- one year of age and older and adult able or metastatic triple-negative breast mental BLA and has also been granted patients with relapsed or refractory cancer whose tumors express PD-L1 as in the United States for the high-risk in the bone or determined by an FDA-approved test. treatment of patients with human bone marrow who have demonstrated a epidermal receptor On Oct. 16, the FDA granted regular partial response, minor response, or • 2-positive metastatic gastric or gastro- approval to Venclexta® () stable disease to prior therapy. esophageal junction adenocarcinoma. (AbbVie Inc., abbvie.com and Genentech • On Dec. 1, the FDA approved Gallium 68 Inc., gene.com) in combination with • Aprea Therapeutics, Inc. (aprea.com) PSMA-11 (Ga 68 PSMA-11) (University of , , or low-dose announced that the FDA has granted fast California, Los Angeles, ucla.edu and the for newly diagnosed acute track designation for eprenetapopt in the University of California, San Francisco, myeloid in adults 75 years or treatment of patients with TP53-mutant ucsf.edu), the first drug for positron older or who have comorbidities acute myeloid leukemia. emission tomography imaging of precluding intensive induction BridgeBio Pharma, Inc. (bridgebio.com) prostate-specific membrane antigen chemotherapy. • announced that the FDA has accepted positive lesions in men with prostate its new drug application (NDA) cancer. Drugs in the News for for individuals with • On Dec. 1, the FDA approved Gavreto™ • The Janssen Pharmaceutical Companies or cancer of the bile () (Blueprint Medicines, of Johnson & Johnson (janssen.com) ducts. blueprintmedicines.com) for adult and announced the submission of a biologics • Regeneron Pharmaceuticals, Inc. pediatric patients 12 years of age and license application (BLA) to the FDA (regeneron.com) announced that the FDA older with advanced or metastatic seeking approval of for the has accepted for priority review its RET-mutant medullary thyroid cancer treatment of patients with metastatic supplemental BLA for PD-1 inhibitor who require systemic therapy or RET non-small cell lung cancer with epidermal Libtayo® (-rwlc) to treat fusion-positive thyroid cancer who (EGFR) exon 20 patients with first-line locally advanced or require systemic therapy and who are insertion mutations whose disease has metastatic non-small cell lung cancer radioactive iodine refractory (if radioac- progressed on or after platinum-based with greater than or equal to 50 percent tive iodine is appropriate). chemotherapy. PD-L1 expression. • On Oct. 14, the FDA extended the • Apexigen, Inc. (apexigen.com) announced • ADC Therapeutics SA (adctherapeutics. approval of Keytruda® (pembrolizumab) that the FDA has granted orphan drug com) announced that the FDA has (Merck, merck.com) for the following designation status to APX005M for the accepted its BLA and granted priority indications: adult patients with relapsed treatment of esophageal and gastro- review status for Lonca (loncastuximab or refractory classical Hodgkin’s esophageal junction cancer and for the tesirine) for the treatment of relapsed or lymphoma and pediatric patients with treatment of pancreatic cancer. refractory diffuse large B-cell lymphoma.

OI | Vol. 36, No. 1, 2021 | accc-cancer.org 21 • Ipsen (ipsen.com) announced that the treatment of adult patients with chronic • Foundation Medicine, Inc. (foundation- FDA has granted fast track designation lymphocytic leukemia. The company has medicine.com) announced that the FDA for Onivyde® ( liposome initiated a rolling submission of a BLA approved FoundationOne® Liquid CDx injection) as a second-line monotherapy to the FDA requesting approval of for three new companion diagnostic treatment of small cell lung cancer. and umbralisib for the indications to help match patients who • Bristol Myers Squibb (bms.com) and treatment of patients with chronic may benefit from treatment with specific lymphocytic leukemia. FDA-approved targeted therapies. The Exelixis, Inc. (exelixis.com) announced ® that the FDA has accepted the supple- • Zymeworks Inc. (zymeworks.com) new indications are for Piqray (alpelisib) in advanced or metastatic breast cancer; mental BLA and supplemental NDA, announced that the FDA has granted ® respectively, for Opdivo® () in Rubraca () in advanced ovarian breakthrough therapy designation for ® combination with Cabometyx® zanidatamab in patients with previously cancer; and Alecensa () in a () for patients with treated human certain type of metastatic non-small cell advanced renal cell carcinoma. receptor 2 gene-amplified biliary tract lung cancer. The FDA also approved a cancer. label expansion for FoundationOne Liquid • PMV Pharmaceuticals, Inc. (pmvpharma. CDx to report additional select copy com) announced that the FDA has Approved Genetic Tests and number alterations and genomic granted fast track designation to rearrangements and an expanded Assays PC14586 for the treatment of patients indication to identify patients with with cancer with locally advanced or • 4D Path (4dpath.com) announced that BRCA1, BRCA2, and/or ATM alterations in metastatic solid tumors that have a p53 metastatic castration-resistant prostate Y220C mutation. the FDA granted breakthrough device designation for its patented comput- cancer who may be appropriate for ® • PTC Therapeutics, Inc. (ptcbio.com) er-aided cancer diagnostic and precision treatment with Lynparza (). announced that the FDA has granted oncology platform, which has demon- • MiR Scientific (mirscientific.com) PTC596 orphan drug designation and fast strated promise of significant improve- announced that it has received FDA track designation for the potential ments over the existing standard of care. breakthrough device designation for its treatment of leiomyosarcoma. Further- miR Sentinel™ PCC4 Assay (miR more, the FDA has granted PTC596 a rare • Roche (roche.com) announced FDA Sentinel Prostate Test). pediatric disease designation and orphan approval of expanded claims for the ® drug designation for the potential cobas EGFR Mutation Test v2 as a • Agilent Technologies Inc. (agilent.com) treatment of diffuse intrinsic pontine companion diagnostic for a broader announced that it has received FDA glioma. group of therapies in the treatment of approval for the use of PD-L1 IHC 22C3 non-small cell lung cancer. This claim • RhoVac (rhovac.com) announced that the pharmDx as an aid in identifying patients expansion allows the test to be used as a with triple-negative breast cancer for FDA granted fast track designation to companion diagnostic for all five ® RV001, the company’s prostate cancer treatment with Keytruda currently FDA-approved EGFR tyrosine (pembrolizumab). drug candidate. kinase inhibitor therapies targeting EGFR • Surface Oncology (surfaceoncology.com) mutations L858R and exon 19 deletions AI Tools announced that the FDA has granted fast in accordance with the approved track designation to SRF388 for the therapeutic product labelling. • Ezra (ezra.com) announced that it has treatment of patients with hepatocellular • enGene Inc. (engene.com) announced received FDA 510(k) premarket authoriza- carcinoma, or liver cancer, who have been that the FDA has granted fast track tion for its artificial intelligence (AI), previously treated with standard designation to enGene for EG-70, the designed to decrease the cost of therapies, such as vascular endothelial company’s lead investigational non-viral magnetic resonance imaging-based growth factor targeted agents and gene therapy, for the treatment of cancer screening, assisting radiologists in programmed death ligand blockade. patients with Bacille Calmette-Guerin- their analysis of prostate magnetic • AstraZeneca (astrazeneca.com) unresponsive non-muscle-invasive resonance imaging scans. It is the first announced it received acceptance from bladder cancer. prostate AI to be cleared by the FDA. the FDA for its supplemental NDA and • The FDA approved the next-generation • Braid Health (braid.health/www) secured has also been granted priority review for sequencing-based FoundationOne®CDx FDA clearance for its AI-powered Tagrisso® () for the adjuvant test (Foundation Medicine, Inc., founda- diagnostic collaboration software, treatment of patients with early stage (IB, tionmedicine.com) as a companion improving diagnostic access and II, and IIIA) EGFR-mutated non-small cell diagnostic to identify fusions in reducing costs for large healthcare lung cancer after complete tumor neurotrophic receptor systems, urgent care clinics, and retail resection with curative intent. (NTRK) genes NTRK1, NTRK2, and NTRK3 clinics. The Braid mobile application • TG Therapeutics, Inc. (tgtherapeutics.com) in DNA isolated from tumor tissue allows providers and radiologists to announced that the FDA has granted fast specimens from patients with solid access, review, and annotate images and track designation to the combination of tumors eligible for treatment with share results with patients in real time ublituximab and umbralisib for the Vitrakvi® (). from any mobile device.

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