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Approved Drugs • on Sept. 4, the U.S. Food and Drug Administration (FDA

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Approved Drugs • on Sept. 4, the U.S. Food and Drug Administration (FDA tools Approved Drugs • On Sept. 8, Athena Bioscience (athenabio- breakthrough therapy designation for science.com) announced that the FDA disitamab vedotin (RC48) for the • On Sept. 4, the U.S. Food and Drug has approved Qdolo™ (tramadol second-line treatment of patients with Administration (FDA) granted accelerated hydrochloride) oral solution 5 mg/1 mL human epidermal growth factor receptor approval to Gavreto™ (pralsetinib) C-IV, an opioid agonist indicated in 2-positive locally advanced or metastatic (Blueprint Medicines Corporation, adults, for the management of pain urothelial cancer who have also previ- blueprintmedicines.com) for adult severe enough to require an opioid ously received platinum-containing patients with metastatic rearranged analgesic and for which alternative chemotherapy treatment. during transfection (RET) fusion-positive treatments are inadequate. non-small cell lung cancer as detected by • Leap Therapeutics, Inc. (leaptx.com) an FDA-approved test. Drugs in the News announced that the FDA has granted fast track designation to DKN-01 for the • On Aug. 20, the Janssen Pharmaceutical • Ascentage Pharma (ascentagepharma. treatment of patients with gastric and Companies of Johnson & Johnson com) announced that the FDA has gastroesophageal junction adenocarci- (janssen.com) and Amgen (amgen.com) granted APG-2575, its novel Bcl-2 noma whose tumors express high announced that the FDA approved the Dickkopf-1 protein, following disease ® inhibitor, orphan drug designation for the expansion of the Kyprolis (carfilzomib) treatment of chronic lymphocytic progression on or after prior fluoropyrimi- prescribing information to include its use dine- and platinum-containing chemo- ® leukemia. The company also announced in combination with Darzalex (daratu- that the FDA has granted two orphan therapy and, if appropriate, human mumab) plus dexamethasone in two drug designations to two of the epidermal receptor growth factor/ dosing regimens—once weekly and twice company’s apoptosis-targeting assets: neu-targeted therapy. weekly—for the treatment of patients the MDM2-p53 inhibitor, APG-115, for with relapsed or refractory multiple • ESSA Pharma Inc. (essapharma.com) the treatment of acute myeloid leukemia; announced that the FDA granted fast myeloma who have received one to three and the Bcl-2/Bcl-xL inhibitor, APG-1252, previous lines of therapy. track designation to EPI-7386 for the for the treatment of small cell lung treatment of adult male patients with • On Sept. 1, Bristol Myers Squibb (bms. cancer. metastatic castration-resistant prostate com) announced that the FDA approved ® • Exelixis (exelixis.com) announced the cancer resistant to standard-of-care Onureg (azacitidine) for the continued submission of supplemental new drug treatment. treatment of adult patients with acute application (NDA) to the FDA for The FDA granted Gavreto™ (pralsetinib) myeloid leukemia who achieved first Cabometyx® (cabozantinib) in combina- • (Blueprint Medicines Corporation, complete remission or complete tion with Opdivo (nivolumab) for blueprintmedicines.com) priority review remission with incomplete blood count advanced renal cell carcinoma. recovery following intensive induction for the treatment of people with chemotherapy and who are not able to • CARsgen Therapeutics Co., Ltd. (carsgen. advanced or metastatic RET-mutant complete intensive curative therapy. com) announced that the FDA has medullary thyroid cancer and RET granted orphan drug designation to fusion-positive thyroid cancer. • On Oct. 2, the FDA approved the CT041 for the treatment of gastric and ® Gan & Lee Pharmaceuticals Co., Ltd. combination of Opdivo (nivolumab) gastroesophageal junction • ® (ganlee.com/en/) announced that the plus Yervoy (ipilimumab) (Bristol-Myers adenocarcinoma. Squibb, bms.com) as first-line treatment FDA has granted orphan drug designation for adult patients with unresectable • RemeGen Co., Ltd. (remegen.com) to GLR2007 for the treatment of malignant pleural mesothelioma. announced that the FDA has granted malignant glioma. 10 accc-cancer.org | November–December 2020 | OI • Bristol Myers Squibb (bms.com) and Paclitaxel) for the treatment of meta- refractory systemic anaplastic large cell bluebird bio, Inc. (bluebirdbio.com) static breast cancer. lymphoma that is anaplastic lymphoma announced that the FDA has accepted for • Kazia Therapeutics Limited (kaziathera- kinase-positive. priority review their biologics license peutics.com) announced that the FDA has • Mersana Therapeutics, Inc. (mersana. application (BLA) for idecabtagene awarded rare pediatric disease designa- com) announce that the FDA has granted vicleucel (ide-cel; bb2121) for the tion to paxalisib (formerly GDC-0084) for fast track designation for XMT-1536 for treatment of adult patients with multiple the treatment of diffuse intrinsic pontine the treatment of patients with plati- myeloma who have received at least three glioma, a rare and highly aggressive num-resistant high-grade serous ovarian prior therapies, including an immuno- childhood brain cancer. cancer who have received up to three modulatory agent, a proteasome prior lines of systemic therapy or patients inhibitor, and an anti-CD38 antibody. • Kazia Therapeutics Limited (kaziathera- peutics.com) announced that the FDA has who have received four prior lines of • AstraZeneca (astrazeneca.com) granted fast track designation to systemic therapy regardless of platinum announced that the FDA has accepted a status. ® paxalisib (formerly GDC-0084) for the supplemental BLA for Imfinzi treatment of glioblastoma, the most • Kite Pharma (kitepharma.com) (durvalumab) and has also been granted common and most aggressive form of announced that it has submitted a priority review for a new four-week, primary brain cancer. supplemental BLA to the FDA for fixed-dose regimen for treatment in the ® • Precision BioSciences, Inc. (precisionbio- Yescarta (axicabtagene ciloleucel) for approved indications of non-small cell the treatment of relapsed or refractory lung cancer and bladder cancer. sciences.com) announced that the FDA has granted fast track designation to follicular lymphoma and marginal zone • ImmunoGen, Inc. (immunogen.com) PBCAR0191, the company’s lead lymphoma after two or more prior lines announced that the FDA has granted investigational allogeneic chimeric of systemic therapy. breakthrough therapy designation for antigen receptor T cell therapy for the IMGN632 for the treatment of patients treatment of advanced B-cell precursor Approved Genetic Tests and with relapsed or refractory blastic acute lymphoblastic leukemia. Assays plasmacytoid dendritic cell neoplasm. • EMD Serono (emdgroup.com/en) • The FDA approved Foundation Medicine, • Alphamab Oncology (alphamabonc.com/ announced that the FDA has accepted Inc.’s (foundationmedicine.com) en/) announced that the FDA has granted and granted priority review to the NDA for FoundationOne®Liquid CDx, a compre- orphan drug designation to KN046 for tepotinib for the treatment of adult hensive pan-tumor liquid biopsy test the treatment of thymic epithelial patients with metastatic non-small cell with multiple companion diagnostic tumors. lung cancer whose tumors have a indications for patients with advanced • Oncopeptides (oncopeptides.se/en) mutation that leads to mesenchymal-ep- cancer. FDA approval includes companion announced that the FDA has granted ithelial transition exon 14 skipping, as diagnostic claims for Rubraca® (rucaparib) priority review for the NDA seeking detected by an FDA-approved test. and three tyrosine kinase inhibitors for approval of melflufen (INN melphalan • G1 Therapeutics, Inc. (g1therapeutics. non-small cell lung cancer. flufenamide) in combination with com) announced that the FDA has • Genetron Holdings Limited (en.genetron- dexamethasone for the treatment of accepted the NDA and granted priority health.com) announced that its blood- adult patients with multiple myeloma review to trilaciclib for small cell lung based next-generation sequencing test whose disease is refractory to at least one cancer patients being treated with HCCscreen™ has been granted break- proteasome inhibitor, one immunomod- chemotherapy. through device designation by the FDA ulatory agent, and one anti-CD38 for early detection of hepatocellular monoclonal antibody. • TG Therapeutics, Inc. (tgtherapeutics.com) announced that the FDA has accepted an carcinoma in individuals who are • The FDA has awarded rare pediatric NDA for umbralisib (TGR-1202) as a designated to be at high risk for disease designation for diffuse intrinsic treatment for patients with previously hepatocellular carcinoma due to chronic pontine glioma and orphan drug treated marginal zone lymphoma who hepatitis B virus infection and/or liver designation for treatment of malignant have received at least one prior anti- cirrhosis. glioma to OKN-007, an investigational CD20-based regimen and follicular • The FDA has granted premarket approval drug discovered at the Oklahoma Medical lymphoma who have received at least to Thermo Fisher Scientific’s (ther- Research Foundation and being devel- two prior systemic therapies. mofisher.com/us/en/home.html) oped by Oblato, Inc. • Pfizer Inc. (pfizer.com) announced that Oncomine Dx Target Test as a compan- • Athenex, Inc. (athenex.com) announced the FDA has accepted and granted priority ion diagnostic to identify patients with that the FDA has accepted for filing the review to the supplemental NDA for RET fusion-positive metastatic non-small NDA and granted priority review for oral Xalkori® (crizotinib) for the treatment of cell lung cancer who are candidates for paclitaxel and encequidar (Oral pediatric patients with relapsed or Gavreto™ (pralsetinib). OI | November–December 2020 | accc-cancer.org 11.
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