Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the US Food and Drug Administration (FDA) has granted breakthrough therapy designation for Venclexta® (venetoclax) in combination with low dose cytarabine (LDAC) for elderly patients with previously untreated AML who are ineligible for intensive chemotherapy. FDA breakthrough therapy designation is intended …
Tag Archives: Breakthrough Therapy
July, 2017
June, 2017
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13 June
FDA Grants Breakthrough Therapy Designation to Omeros’ MASP-2 Inhibitor for the Treatment of IgA Nephropathy
SEATTLE–(BUSINESS WIRE)–Omeros Corporation (NASDAQ: OMER) today announced that the US Food and Drug Administration (FDA) has granted breakthrough therapy designation to OMS721 for the treatment of Immunoglobulin A (IgA) nephropathy. OMS721 is Omeros’ lead human monoclonal antibody targeting mannan-binding lectin-associated serine protease-2 (MASP-2), the effector enzyme of the lectin pathway …
May, 2017
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31 May
FDA Grants Breakthrough Therapy Designation to Alnylam’s Acute Hepatic Porphyria Drug
CAMBRIDGE, Mass.–(BUSINESS WIRE)–Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, announced today that it has received Breakthrough Therapy designation from the U.S. Food and Drug Administration (FDA) for givosiran (ALN-AS1), an investigational RNAi therapeutic targeting aminolevulinic acid synthase 1 (ALAS1) for the prophylaxis of attacks in patients with acute hepatic porphyria (AHP). …
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19 May
GlycoMimetics’ Investigational Acute Myeloid Leukemia Drug Receives Breakthrough Therapy Designation from the FDA
ROCKVILLE, Md.–(BUSINESS WIRE)–GlycoMimetics, Inc. (NASDAQ: GLYC) today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for treatment of adult relapsed/refractory acute myeloid leukemia (AML) to the company’s drug candidate GMI-1271, an E-selectin antagonist currently being evaluated in the Phase 2 portion of a Phase …
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15 May
FDA Grants Breakthrough Therapy Designation to Ignyta’s Cancer Drug Entrectinib
SAN DIEGO–(BUSINESS WIRE)–Ignyta, Inc. (Nasdaq: RXDX), a biotechnology company focused on precision medicine in oncology, today announced that the U.S. Food and Drug Administration (FDA) has granted a Breakthrough Therapy Designation (BTD) to entrectinib “for the treatment of NTRK fusion-positive, locally advanced or metastatic solid tumors in adult and pediatric …
April, 2017
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28 April
Pfizer’s Lorlatinib Receives Breakthrough Therapy Designation from the FDA for ALK-Positive NSCLC
NEW YORK–(BUSINESS WIRE)–Pfizer Inc. today announced that its investigational next-generation ALK/ROS1 tyrosine kinase inhibitor, lorlatinib, was granted Breakthrough Therapy designation from the U.S. Food and Drug Administration (FDA) for the treatment of patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC), previously treated with one or more …
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19 April
FDA Grants Breakthrough Therapy and Regenerative Advanced Therapy Designation to Enzyvant’s RVT-802
BASEL, Switzerland, April 17, 2017 /PRNewswire/ — Enzyvant, a biopharmaceutical company focused on developing innovative treatments for patients with rare diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted RVT-802, Enzyvant’s investigational tissue-based therapy for the treatment of complete DiGeorge Syndrome (cDGS), Breakthrough Therapy designation as …
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18 April
Novartis’ CAR-T Therapy Receives Breakthrough Therapy Designation for Diffuse Large B-Cell Lymphoma
Basel, April 18, 2017 – Novartis announced today that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to CTL019, an investigational chimeric antigen receptor T cell (CAR-T) therapy, for the treatment of adult patients with relapsed and refractory (r/r) diffuse large B-cell lymphoma (DLBCL), who have …
March, 2017
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24 March
FDA Grants Breakthrough Therapy Designation to Genentech’s Rituxan for Treatment of Pemphigus Vulgaris
SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation status to Rituxan® (rituximab) for pemphigus vulgaris, a rare, serious and life-threatening condition characterized by progressive painful blistering of …
November, 2016
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22 November
Genmab Announces FDA Approval of Darzalex for Treatment of Multiple Myeloma
Copenhagen, Denmark; November 21, 2016 — Genmab A/S (Nasdaq Copenhagen: GEN) announced today the U.S. Food and Drug Administration (FDA) has approved the use of DARZALEX® (daratumumab) in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of patients with multiple myeloma who have received at least …