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Approved Drugs • On March 3, the FDA granted regular for a new drug application (NDA) for the approval to Lorbrena® (lorlatinib) (Pfizer, hypoxia-inducible factor-2 alpha inhibitor • On Feb. 12, G1 Therapeutics, Inc. pfizer.com) for patients with metastatic belzutifan (MK-6482) for the potential (g1therapeutics.com) announced that the NSCLC whose tumors are anaplastic treatment of patients with von U.S. Food and Drug Administration (FDA) lymphoma kinase ALK-positive, detected Hippel-Lindau disease-associated renal approved Cosela™ (trilaciclib) to decrease by an FDA-approved test. cell carcinoma not requiring immediate the incidence of - • On Feb. 26, the FDA granted accelerated surgery. induced myelosuppression in adult ® patients when administered prior to a approval to Pepaxto ( • BeiGene (beigene.com) announced that platinum/etoposide-containing regimen flufenamide) (Oncopeptides, the FDA has accepted a supplemental ® or -containing regimen for oncopeptides-us.com/en) in combination NDA for Brukinsa (zanubrutinib) for the extensive-stage small cell lung cancer. with dexamethasone for adult patients treatment of adult patients with with relapsed or refractory multiple Waldenström’s macroglobulinemia. • On March 10, the FDA approved Fotivda® myeloma who have received at least four (tivozanib) (AVEO Pharmaceuticals, prior lines of therapy and whose disease • Exelixis (exelixis.com) announced that the aveooncology.com) for adult patients FDA granted breakthrough therapy is refractory to at least one proteasome ® with relapsed or refractory advanced renal inhibitor, one immunomodulatory agent, designation to Cabometyx cell carcinoma following two or more and one CD38-directed monoclonal (cabozantinib) as a potential treatment prior systemic therapies. antibody. for patients with differentiated thyroid Q3 cancer that has progressed following • On March 22, the FDA approved • On March 5, the FDA granted accelerated ® prior therapy and who are radioactive Keytruda (pembrolizumab) (Merck, approval to Yescarta® (axicabtagene iodine-refractory (if radioactive iodine is Merck.com) in combination with ciloleucel) (Kite Pharma, kitepharma. appropriate). platinum- and fluoropyrimidine-based com) for adult patients with relapsed or chemotherapy for patients with refractory follicular lymphoma after two • Celsion Corporation (celsion.com) metastatic or locally advanced esopha- or more lines of systemic therapy. announced that it has received FDA fast geal or gastroesophageal carcinoma who track designation for GEN-1 for the are not candidates for surgical resection Drugs in the News treatment of advanced ovarian cancer. or definitive chemoradiation. • Incyte (incyte.com) announced that the Novartis (novartis.com) announced that • On Feb. 22, the FDA approved Libtayo® • FDA accepted for priority review the asciminib (ABL001) has been granted ® (cemiplimab-rwlc) (Regeneron Pharma- supplemental NDA for Jakafi breakthrough therapy designation by the ceuticals, regeneron.com) for the first-line (ruxolitinib) for treatment of steroid- FDA for the treatment of adult patients treatment of patients with advanced refractory chronic graft-versus-host with Philadelphia chromosome-positive non-small cell lung cancer (NSCLC; locally disease in adult and pediatric patients 12 chronic myeloid leukemia in chronic advanced who are not candidates for years and older. phase, previously treated with two or surgical resection or definitive chemora- more tyrosine kinase inhibitors and for Merck (merck.com) has voluntarily diation or metastatic) whose tumors • the treatment of adult patients with withdrawn the U.S. indication for its have high programmed death ligand 1 Philadelphia chromosome-positive checkpoint inhibitor Keytruda® expression as determined by an FDA- chronic myeloid leukemia in chronic (pembrolizumab) in metastatic small cell approved test, with no epidermal growth phase harboring the T315I mutation. lung cancer. factor receptor (EGFR), anaplastic lymphoma kinase (ALK), or C-ros • Merck (merck.com) announced that the • Seagen (seagen.com) and Astellas oncogene-1 (ROS-1) aberrations. FDA accepted and granted priority review Pharma (astellas.com) announced the

14 accc-cancer.org | Vol. 36, No. 3, 2021 | OI completion of two supplemental patients with KRAS G12C-mutated locally company’s PD-L1 IHC 22C3 pharmDx biologics license application (BLA) advanced or metastatic NSCLC, following assay for expanded use in patients with submissions to the FDA for Padcev® at least one prior systemic therapy. NSCLC. (enfortumab vedotin-ejfv). One Roche (roche.com) announced that the submission seeks to convert Padcev’s • • Natera, Inc. (natera.com) announced that company is voluntarily withdrawing the accelerated approval to regular approval, the FDA granted two breakthrough device U.S. indication for Tecentriq® and the second submission requests an designations covering new intended uses (atezolizumab) in prior platinum-treated expansion of the current label to include of the Signatera™ molecular residual metastatic urothelial carcinoma. patients with locally advanced or disease test. Its performance has been metastatic urothelial cancer who • Seagen (seagen.com) and Genmab clinically validated in multiple cancer have been previously treated with a (genmab.com) announced the submis- types including colorectal, NSCLC, breast, programmed cell death protein 1/ sion of a BLA to the FDA seeking and bladder cancers. programmed death ligand 1 inhibitor and accelerated approval for tisotumab • Roche (roche.com) announced FDA are ineligible for . vedotin for the treatment of patients approval of the Ventana ALK (D5F3) CDx with recurrent or metastatic cervical Steba Biotech announced that the FDA Assay as a companion diagnostic to • cancer with disease progression on or granted orphan drug designation to identify patients with ALK-positive NSCLC after chemotherapy. padeliporfin for the treatment of adult eligible for treatment with Lorbrena® patients with upper tract urothelial • Shanghai Junshi Biosciences Co., Ltd. (lorlatinib). cancer. (junshipharma.com/en/AboutUs.html) and Coherus Biosciences (coherus.com) Other Oncology-Related On Target Laboratories (ontargetlabs. • announced the initiation of the rolling Products in the News com) announced that the FDA accepted submission of the BLA for toripalimab to its NDA for priority review for the FDA for the treatment of recurrent or • Boston Scientific Corporation (bostonsci- pafolacianine sodium injection as an metastatic nasopharyngeal carcinoma. entific.com) announced it has received adjunct for identifying ovarian cancer FDA approval of the TheraSphere™ Y-90 during surgery. • Sesen Bio (sesenbio.com) announced that Glass Microspheres for the treatment of the FDA accepted for filing and granted Spectrum Pharmaceuticals (sppirx.com) patients with hepatocellular carcinoma. • priority review its BLA for Vicineum for announced that the FDA granted fast the treatment of high-risk, bacillus • Optellum (optellum.com) announced it track designation for poziotinib for the calmette-guerin (BCG)-unresponsive received FDA 510(k) clearance for its treatment of NSCLC in previously treated non-muscle invasive bladder cancer. Virtual Nodule Clinic, an artificial patients with human epidermal growth intelligence-powered clinical decision factor receptor 2 (HER2) exon 20 Devices, Genetic Tests, and support software for pulmonologists and mutations. Assays in the News radiologists managing patients with • Amgen (amgen.com) announced that the small lesions in the lungs (nodules) that FDA has granted priority review for • Agilent Technologies (agilent.com) could represent early-stage lung cancer. sotorasib (AMG 510) for the treatment of announced that the FDA approved the

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