Daily Top News – July 30, 2020

July 30, 2020

llllllllll Tagrisso (osimertinib) / AstraZeneca
Tagrisso granted Breakthrough Therapy Designation in the US for the adjuvant treatment of patients with Stage IB-IIIA EGFR-mutated lung cancer (AstraZeneca Press Release) – Jul 30, 2020 – “AstraZeneca’s Tagrisso (osimertinib) has been granted Breakthrough Therapy Designation (BTD) in the US for the adjuvant treatment of patients with early-stage (IB, II and IIIA) epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC) after complete tumour resection with curative intent…The FDA granted the BTD based on data from the Phase III ADAURA trial…ADAURA is a randomised, double-blinded, global, placebo-controlled Phase III trial in the adjuvant treatment of 682 patients with Stage IB, II, IIIA EGFRm NSCLC…The data readout was originally anticipated in 2022.”


llllllllll Lenvima (lenvatinib) / Eisai, Merck (MSD)
APPLICATION FOR ADDITIONAL INDICATION OF ANTI CANCER AGENT LENVIMA FOR UNRESECTABLE THYMIC CARCINOMA SUBMITTED IN JAPAN (Eisai Press Release) – Jul 30, 2020 – “Eisai…and MSD…announced today that Eisai has submitted an application in Japan for the additional indication of treatment of unresectable thymic carcinoma for multiple receptor tyrosine kinase inhibitor LENVIMA ® (generic name: lenvatinib mesylate). In June 2020, LENVIMA received orphan drug designation in Japan for unresectable thymic carcinoma. This application is based on the results of an open-label, single-arm, multicenter, investigator-initiated clinical phase II study (NCCH1508) conducted in Japan…”


llllllllll bomedemstat (IMG-7289) / Imago BioSciences
Imago BioSciences Granted Access by European Medicines Agency to PRIME Scheme for IMG-7289 (Bomedemstat) in Myelofibrosis (Businesswire) – Jul 30, 2020 – “Imago BioSciences, Inc…announced that the European Medicines Agency (EMA) granted access to its PRIME (PRIority MEdicines) scheme for IMG-7289 (bomedemstat), a lysine-specific demethylase-1 (LSD1) inhibitor, for the treatment of intermediate-2 and high-risk patients with myelofibrosis who have become intolerant of, resistant to, or are ineligible for a Janus Kinase (JAK) inhibitor.”


llllllllll pevonedistat (MLN4924) / Takeda
Takeda Announces U.S. FDA Breakthrough Therapy Designation Granted for Pevonedistat for the Treatment of Patients with Higher-Risk Myelodysplastic Syndromes (HR-MDS) (Businesswire) – Jul 30, 2020 – “Takeda Pharmaceutical Company Limited…announced that the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation for its investigational drug pevonedistat for the treatment of patients with higher-risk myelodysplastic syndromes (HR-MDS)…The Breakthrough Therapy Designation is based on the final analysis of the Pevonedistat-2001 Phase 2 study, which evaluated pevonedistat plus azacitidine versus azacitidine alone in patients with rare leukemias, including HR-MDS.”


llllllllll Keytruda (pembrolizumab) / Merck (MSD)
Merck Announces Two US Regulatory Milestones for KEYTRUDA (pembrolizumab) in Triple-Negative Breast Cancer (TNBC) (Businesswire) – Jul 30, 2020 – “The FDA has accepted and granted priority review for a new sBLA seeking accelerated approval for KEYTRUDA in combination with chemotherapy for the treatment of patients with locally recurrent unresectable or metastatic triple-negative breast cancer (TNBC) whose tumors express PD-L1 (Combined Positive Score [CPS] ≥10), based on the Phase 3 KEYNOTE-355 trial. The FDA has set a Prescription Drug User Fee Act (PDUFA), or target action, date of Nov. 28, 2020. The FDA also accepted for standard review a new sBLA for KEYTRUDA for the treatment of patients with high-risk early-stage TNBC, in combination with chemotherapy as neoadjuvant treatment, and then as a single agent as adjuvant treatment after surgery, based on the Phase 3 KEYNOTE-522 trial. The PDUFA date for this application is March 29, 2021.”

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