Multiple Myeloma

AbbVie Provides Update on VENCLEXTA®/VENCLYXTO® (venetoclax) Multiple Myeloma Program

(AbbVie) Mar 19, 2019 - AbbVie, a research-based global biopharmaceutical company, today announced the U.S. Food and Drug Administration (FDA) has placed a partial clinical hold on all clinical trials evaluating venetoclax (VENCLEXTA®/VENCLYXTO®) for the investigational treatment of multiple myeloma. The partial clinical hold follows a review of data from the ongoing Phase 3 BELLINI trial (M14-031), a study in relapsed/refractory multiple myeloma, in which a higher proportion of deaths was observed in the venetoclax arm compared to the control arm of the trial. As a result of this action, no new patients should be enrolled in any studies of venetoclax for multiple myeloma until a further analysis of the data is completed. Patients who are currently enrolled in studies and receiving benefit from the therapy may continue with treatment, after consultation with their physician.

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Karyopharm Announces FDA Extension of Review Period for Selinexor New Drug Application

(Karyopharm) Mar 14, 2019 - Karyopharm Therapeutics Inc., a clinical-stage pharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) action date for the New Drug Application (NDA) for selinexor. The NDA, which is currently under Priority Review by the FDA, is seeking accelerated approval for selinexor in combination with dexamethasone for the treatment of patients with relapsed refractory multiple myeloma who have received at least three prior therapies and whose disease is refractory to at least one proteasome inhibitor (PI), one immunomodulatory agent (IMiD), and one anti-CD38 monoclonal antibody. The previously disclosed April 6, 2019 PDUFA date has been extended by three months to July 6, 2019.

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U.S. Court Rejects Alvogen's Patent Challenge For Celgene's Cancer Drug

(Reuters) Mar 14, 2019 - The U.S. patent office on Thursday rejected a filing by Alvogen Pine Brook Llc for a review challenging patents on Celgene Corp’s blockbuster myeloma drug Revlimid.

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Janssen Submits Application to U.S. FDA Seeking Approval of DARZALEX® (daratumumab) Combination Therapy for Patients with Newly Diagnosed Multiple Myeloma Who Are Transplant Ineligible

(Janssen) Mar 12, 2019 - The Janssen Pharmaceutical Companies of Johnson & Johnson announced today the submission of a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) seeking approval of DARZALEX® (daratumumab) in combination with lenalidomide and dexamethasone (Rd) for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant (ASCT). The sBLA, based upon data from the Phase 3 MAIA (MMY3008) clinical study, is being reviewed by the FDA under the Real-Time Oncology Review (RTOR) pilot program, which for certain applications allows the FDA to review data before the applicant formally submits the complete application. It aims to explore a more efficient review process to help ensure treatments are available as soon as possible for patients. Selection into the RTOR pilot program does not guarantee or influence approvability of the supplemental application.

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NICE U-Turn Backs Use Of Darzalex Combo For Myeloma Relapse

(PharmaTimes [UK]) Mar 12, 2019 - Myeloma patients in England are set to gain NHS access to a new second-line treatment combination following a first relapse of the disease.

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Imbrium Therapeutics Announces Enrollment of the First Patient in Expansion Phase of Tinostamustine Trial in Patients with Difficult-to-Treat Blood Cancers

(AP) Mar 5, 2019 - Imbrium Therapeutics L.P. today announced that they have enrolled the first patient in the expansion stage of a Phase 1/2 clinical trial of tinostamustine, an investigational treatment, in patients with relapsed refractory (R/R) hematologic malignancies in the U.S. and Europe.

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Dana-Farber Opens Center For The Prevention Of Progression Clinic

(Dana-Farber) Mar 4, 2019 - First of its kind clinic will focus on precursor conditions in blood cancers.

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NantKwest Signs Worldwide License Agreement with ProMab Biotechnologies to Exclusively Develop Select Next Generation Targeted Natural Killer Cell Therapeutics

(AP) Mar 4, 2019 - Initially Launching a novel, high-affinity BCMA CAR targeting NK cell development candidate for multiple myeloma, with an option for up to five additional car targeting sequences.

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First Clinical Results Evaluating Allogeneic, Off-The-Shelf, Placental-Derived Cells to be Presented by Celularity at 2019 AACR Annual Meeting

(MarketWatch) Feb 27, 2019 - First in-human clinical presentation of company’s PNK allogeneic cell therapy in patients with acute myeloid leukemia- clinical presentation of company’s PNK allogeneic cell therapy in patients with multiple myeloma.

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Adcom Gives Karyopharm a Second Chance With Selinexor

(Vantage) Feb 27, 2019 - Incredibly, a US FDA panel has left the door open for approval of Karyopharm’s selinexor in multiple myeloma, despite concerns about safety. The approval of Karyopharm Therapeutics’ selinexor in multiple myeloma has been delayed on worries about its efficacy and, more importantly, safety. But a US FDA advisory committee stopped short of rejecting the project outright yesterday in a vote that was closer than had been expected.

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Karyopharm Announces Outcome of FDA Advisory Committee Meeting Reviewing Selinexor for the Treatment of Patients with Triple Class Refractory Multiple Myeloma

(Karyopharm) Feb 26, 2019 - Karyopharm Therapeutics Inc., a clinical-stage pharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) met to discuss the New Drug Application (NDA) for selinexor, a first-in-class, oral Selective Inhibitor of Nuclear Export (SINE) compound. The NDA, which is currently under Priority Review by the FDA, is seeking accelerated approval for selinexor in combination with dexamethasone for the treatment of patients with relapsed refractory multiple myeloma who have received at least three prior therapies and whose disease is refractory to at least one proteasome inhibitor (PI), one immunomodulatory agent (IMiD), and one anti-CD38 monoclonal antibody. The ODAC voted 8 to 5 recommending that the FDA wait for the results from Karyopharm’s randomized, open-label, Phase 3 BOSTON study evaluating selinexor in patients with relapsed or refractory multiple myeloma, before making a final decision regarding approval.

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FDA Staff Hammers Karyopharm Cancer Drug on Safety, Efficacy Concerns

(Xconomy Boston) Feb 22, 2019 - A Karyopharm Therapeutics multiple myeloma drug candidate faces longer odds for speedy FDA approval after the agency’s staff raised questions about the therapy’s efficacy and safety. Staff concerns about Karyopharm drug selinexor were detailed in briefing documents posted Friday afternoon, ahead of an advisory committee meeting scheduled for Tuesday. Such panels are convened to assess the risks and benefits of new drugs, and to vote on whether to recommend approval. Shares of Newton, MA-based Karyopharm sank more than 43 percent on the news, closing at $5.07 on Friday.

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FDA Panel Says Karyopharm's Cancer Drug Shows 'Significant Toxicity'

(Boston Business Journal) Feb 25, 2019 - The company's path forward is uncertain after FDA officials wrote in an advisory committee briefing document Friday that Karyopharm's drug was linked to "significant toxicity" and potentially lowered cancer patients' survival rates. "It is unclear whether treatment with selinexor-dexamethasone provides a clinically meaningful benefit that outweighs the risks of treatment," the committee report read. On Monday, Karyopharm announced Michael Mason as its new senior vice president and chief financial officer and treasurer. He previously worked for 13 years at Cambridge-based Alnylam Pharmaceuticals, most recently as vice president of finance and treasurer.

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Genmab Announces Positive Topline Results in Phase III COLUMBA Study of Subcutaneous Daratumumab

(NASDAQ) Feb 25, 2019 - Phase III COLUMBA study comparing the subcutaneous formulation of daratumumab to the intravenous formulation in patients with relapsed or refractory multiple myeloma met both co-primary endpoints. Results show that daratumumab administered subcutaneously was non-inferior in efficacy and pharmacokinetics as compared to daratumumab administered intravenously. Data will be discussed with health authorities to prepare for regulatory filings in support of bringing convenience of subcutaneous daratumumab option to patients.

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Roswell Park Presentations at TCT 2019 Focus on Tools for Predicting Patient Outcomes

(RPCI) Feb 21, 2019 - Dr. Theresa Hahn wins Best Abstract Award for new way of assessing prognosis for multiple myeloma patients.

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Cellectar Reports Positive Top-line Response Rate of 30% from R/R Multiple Myeloma Cohort in Ongoing Phase 2 Study of CLR 131

(Yahoo! Finance) Feb 25, 2019 - Company’s lead product candidate previously demonstrated positive top-line results from the diffuse large B-cell lymphoma cohort of this study. Dosing in multiple tumor types is ongoing; Cellectar intends to report additional data this year.

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Gamida Cell Presents New Data from Ongoing Phase 1 Study of NAM-NK and Initial Data from Phase 1/2 Study of NiCord® in Severe Aplastic Anemia at 2019 TCT Annual Meeting

(Yahoo! Finance) Feb 21, 2019 - Gamida Cell Ltd. today announced that new data from its NAM-NK and NiCord® programs was presented at the 2019 Transplantation & Cellular Therapy (TCT) Meetings of American Society for Blood and Marrow Transplantation and Center for International Blood and Marrow Transplant Research taking place in Houston, Texas.

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U.S. FDA Approves DARZALEX® (daratumumab) Split-Dosing Regimen

(J&J) Feb 12, 2019 - The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that the U.S. Food and Drug Administration (FDA) has approved a split-dosing regimen for DARZALEX® (daratumumab), providing healthcare professionals and patients with multiple myeloma an option to split the first infusion over two consecutive days.

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AbbVie and Teneobio Announce a Strategic Transaction to Develop a New Treatment for Multiple Myeloma

(Markets Insider) Feb 11, 2019 - AbbVie, Teneobio, Inc. and its affiliate TeneoOne, Inc. announced today that they have entered a global strategic transaction to develop and commercialize TNB-383B, a BCMA-targeting immunotherapeutic for the potential treatment of multiple myeloma.

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Karyopharm Announces FDA Advisory Committee Meeting to Review Selinexor for the Treatment of Patients with Triple Class Refractory Multiple Myeloma Who Have Received At Least Three Prior Therapies

(Yahoo! Finance) Feb 7, 2019 - Karyopharm Therapeutics Inc. today announced that the Oncologic Drugs Advisory Committee (ODAC) of the U.S. Food and Drug Administration (FDA) is scheduled to review data supporting the Company’s New Drug Application (NDA) requesting accelerated approval for selinexor, a first-in-class, oral Selective Inhibitor of Nuclear Export (SINE) compound, at a meeting on February 26, 2019 at 12:30 p.m. The proposed indication to be discussed at this upcoming ODAC meeting is for selinexor in combination with dexamethasone for the treatment of patients with refractory multiple myeloma who have received at least three prior therapies and whose disease is refractory to at least one proteasome inhibitor (PI), one immunomodulatory agent (IMiD), and one anti-CD38 monoclonal antibody, and to their most recent treatment regimen. The ODAC is an independent panel of experts that evaluates data concerning the efficacy and safety of marketed and investigational products for use in the treatment of cancer and makes appropriate recommendations to the FDA.

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