Daily Top News – July 24, 2020

July 24, 2020

llllllllll brexucabtagene autoleucel (KTE-X19) / Gilead
U.S. FDA Approves Kite’s Tecartus, the First and Only CAR T Treatment for Relapsed or Refractory Mantle Cell Lymphoma (Gilead Press Release) – Jul 24, 2020 – “Kite, a Gilead Company…announced that the…FDA has granted accelerated approval to Tecartus™ (brexucabtagene autoleucel, formerly KTE-X19), the first and only approved chimeric antigen receptor (CAR) T cell therapy for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL). The approval of this one-time therapy follows a priority review and FDA Breakthrough Therapy Designation and is based on results of ZUMA-2, a single-arm, open-label study in which 87 percent of patients responded to a single infusion of Tecartus, including 62 percent of patients achieving a complete response (CR).”

 

llllllllll Arikace (amikacin liposome inhalation suspension) / Insmed
Insmed Receives Positive CHMP Opinion for ARIKAYCE Liposomal 590 mg Nebuliser Dispersion for the Treatment of NTM Lung Infections Caused by MAC in Non-CF Patients with Limited Treatment Options (PRNewswire) – Jul 24, 2020 – “Insmed Incorporated…today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has adopted a positive opinion recommending ARIKAYCE Liposomal 590 mg Nebuliser Dispersion for the treatment of non-tuberculous mycobacterial (NTM) lung infections caused by Mycobacterium avium complex (MAC) in adults…The European Commission (EC) will review the CHMP opinion, with a final decision anticipated in the second half of 2020….The CHMP opinion is based on results from the Phase 3 CONVERT study.”

 

llllllllll Imbruvica (ibrutinib) / AbbVie, J&J; Rituxan (rituximab) / Biogen, Zenyaku Kogyo, Roche
Janssen Receives CHMP Positive Opinion for Expanded Use of IMBRUVICA (ibrutinib) in Combination with Rituximab for Previously Untreated Patients with Chronic Lymphocytic Leukaemia (CLL) (Businesswire) – Jul 24, 2020 – “The Janssen Pharmaceutical Companies of Johnson & Johnson today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a Positive Opinion recommending marketing authorisation for IMBRUVICA® (ibrutinib) to include the combination with rituximab for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL)….The Positive Opinion is based on data from the Phase 3 E1912 study…”

 

llllllllll Jyseleca (filgotinib) / Gilead
GILEAD AND GALAPAGOS ANNOUNCE POSITIVE EUROPEAN CHMP OPINION FOR JYSELECA (FILGOTINIB) FOR THE TREATMENT OF ADULTS WITH MODERATE TO SEVERE RHEUMATOID ARTHRITIS (GlobeNewswire) – Jul 24, 2020 – “Gilead Sciences, Inc….announced today the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for Jyseleca® (filgotinib 200 mg and 100 mg tablets), an investigational, once-daily, oral, selective JAK1 inhibitor for the treatment of adults with moderate to severe rheumatoid arthritis (RA) who have responded inadequately or are intolerant to one or more disease modifying anti-rheumatic drugs (DMARDs). The CHMP positive opinion is a scientific recommendation to the European Commission to grant marketing authorization in Europe….Supported by data from the Phase 3 FINCH and Phase 2 DARWIN programs…A Commission decision is expected in the third quarter of 2020.”

 

llllllllll Breztri Aerosphere (budesonide/formoterol fumarate/glycopyrronium) / AstraZeneca
Breztri Aerosphere approved in the US for the maintenance treatment of COPD (AstraZeneca Press Release) – Jul 24, 2020 – “AstraZeneca’s Breztri Aerosphere (budesonide/glycopyrrolate/formoterol fumarate) has been approved in the US for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD)…The approval by the US Food and Drug Administration (FDA) was based on positive results from the Phase III ETHOS trial in which Breztri Aerosphere…The approval was also supported by efficacy and safety data from the Phase III KRONOS trial.”

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