RRMM

TECVAYLI® (teclistamab-cqyv) biweekly dosing approved by the U.S. FDA for the treatment of patients with relapsed or refractory multiple myeloma

Retrieved on: 
Tuesday, February 20, 2024

HORSHAM, Pa., Feb. 20, 2024 /PRNewswire/ -- Johnson & Johnson announced today that the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for TECVAYLI® (teclistamab-cqyv) for a reduced dosing frequency of 1.5 mg/kg every two weeks (Q2W) in patients with relapsed or refractory multiple myeloma (RRMM) who have achieved and maintained a complete response (CR) or better for a minimum of six months.1 There is a continued unmet need for patients with multiple myeloma and this approval allows increased flexibility in dosing schedule for appropriate patients with a weight-based regimen.

Key Points: 
  • Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.
  • TECVAYLI® has been prescribed to more than 3,600 patients in the U.S. since approval.3
    This approval is based on results from the Phase 1/2 MajesTEC-1 study ( Phase 1: NCT03145181 ; Phase 2: NCT04557098 ).
  • Today's approval of biweekly dosing for eligible patients will further enable clinicians to meet the individual needs of patients who may want flexibility in their dosing schedules," said Rachel Kobos, M.D., Vice President, Oncology Research & Development, Johnson & Johnson Innovative Medicine.
  • "As the first bispecific approved for the treatment of multiple myeloma, combined with the longest in-market experience by physicians, TECVAYLI is another example of our commitment to pioneering cutting-edge research to help improve outcomes for patients with multiple myeloma."

ELREXFIO™ is authorized by Health Canada for adults with relapsed or refractory multiple myeloma in Canada

Retrieved on: 
Tuesday, February 13, 2024

KIRKLAND, QC, Feb. 13, 2024 /CNW/ - Today, Pfizer Canada announced that Health Canada has granted a Notice of Compliance with conditions (NOC/c) to ELREXFIO (elranatamab solution for injection).

Key Points: 
  • KIRKLAND, QC, Feb. 13, 2024 /CNW/ - Today, Pfizer Canada announced that Health Canada has granted a Notice of Compliance with conditions (NOC/c) to ELREXFIO (elranatamab solution for injection).
  • "The approval of ELREXFIO is good news for patients and their healthcare teams as it offers a new treatment possibility for those living with the disease."
  • Multiple myeloma is the second-most common type of blood cancer, with an estimated 11 Canadians being diagnosed with myeloma every day.iii It is estimated that in 2023, 3,900 Canadians were diagnosed with multiple myeloma and 1,700 Canadians died from the disease.iv
    "Multiple myeloma can be an incredibly challenging cancer to live with and manage," said Martine Elias, Executive Director at Myeloma Canada.
  • This is why it's so important that people living with the disease have access to many and new options even more so when they have relapsed."

Gracell Biotechnologies Announces FDA Clearance of IND Application for Phase 1 Clinical Trial of FasTCAR-T GC012F as Early-Line Treatment of Multiple Myeloma

Retrieved on: 
Monday, January 29, 2024

“We are extremely pleased to receive our third U.S. IND clearance for our lead FasTCAR candidate GC012F, now expanding company-sponsored investigation into early-line multiple myeloma,” said Dr. William Cao, founder, Chairman and Chief Executive Officer of Gracell.

Key Points: 
  • “We are extremely pleased to receive our third U.S. IND clearance for our lead FasTCAR candidate GC012F, now expanding company-sponsored investigation into early-line multiple myeloma,” said Dr. William Cao, founder, Chairman and Chief Executive Officer of Gracell.
  • This is the third U.S. IND clearance for GC012F.
  • In addition to the ELMM study, GC012F is being evaluated in an ongoing Phase 1b/2 U.S. IND study for the treatment of relapsed/refractory multiple myeloma (RRMM) and in a Phase 1/2 clinical trial for the treatment of refractory systemic lupus erythematosus (rSLE) that will initiate in 2024.
  • GC012F is also being evaluated in four investigator-initiated trials (IIT) for the treatment of rSLE, RRMM, newly-diagnosed multiple myeloma (NDMM) and B-cell non-Hodgkin lymphoma (B-NHL).

Florida Cancer Specialists & Research Institute Best Practices Program Improves Treatment Response and Survival for Patients with Multiple Myeloma

Retrieved on: 
Thursday, January 25, 2024

FORT MYERS, Fla., Jan. 25, 2024 /PRNewswire/ -- A best practices program developed at Florida Cancer Specialists & Research Institute (FCS) has been shown to improve outcomes for adult patients prescribed selinexor for the treatment of relapsed/refractory multiple myeloma (RRMM).

Key Points: 
  • A real-world study by FCS authors details a program to improve patient outcomes for multiple myeloma.
  • Results obtained from a one-year retrospective observational study using data collected by FCS' Real-World Evidence team were recently published in Current Oncology.
  • He added, "Our findings, as detailed in this article, support the hypothesis that a best practices program designed around specific anticancer drugs can optimize prescribing practices, leading to better disease control and improvements in a patient's cancer care journey."
  • The FCS Real-World Evidence team works with internal and external partners providing insights to improve treatment decisions and clinical outcomes based on evidence generated using real-world data.

Gracell Biotechnologies Announces China NMPA Clearance for IND Application for Phase 1/2 Clinical Trial of FasTCAR-T GC012F for the Treatment of Refractory Systemic Lupus Erythematosus

Retrieved on: 
Thursday, December 21, 2023

SAN DIEGO and SUZHOU, China and SHANGHAI, China, Dec. 21, 2023 (GLOBE NEWSWIRE) -- Gracell Biotechnologies Inc. (“Gracell” or the “Company”, NASDAQ: GRCL), a global clinical-stage biopharmaceutical company dedicated to developing innovative and highly efficacious cell therapies for the treatment of cancer and autoimmune disease, today announced that the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA) has cleared Gracell's Investigational New Drug (IND) application for GC012F, an autologous CAR-T therapeutic candidate, for the treatment of refractory systemic lupus erythematosus (rSLE).

Key Points: 
  • Under the IND, Gracell plans to initiate a Phase 1/2 clinical study in China to further evaluate GC012F in rSLE patients.
  • As announced Nov. 27, the Company will also commence Phase 1/2 clinical study in the U.S. An IIT is underway to evaluate GC012F for the treatment of rSLE.
  • “This milestone marks our rapid progress in advancing development of GC012F in rSLE, an autoimmune disease with high unmet need,” said Dr. William Cao, founder, Chairman and Chief Executive Officer of Gracell.
  • GC012F is an autologous CAR-T therapeutic candidate dual-targeting B cell maturation antigen (BCMA) and CD19 and utilizes Gracell’s proprietary FasTCAR next-day manufacturing platform.

Harpoon Therapeutics Presents HPN217 Phase 1 Clinical Data in Relapsed/Refractory Multiple Myeloma (RRMM) at ASH 2023 and Announces Selection of Recommended Phase 2 Dose (RP2D)

Retrieved on: 
Tuesday, December 12, 2023

SOUTH SAN FRANCISCO, Calif., Dec. 11, 2023 (GLOBE NEWSWIRE) -- Harpoon Therapeutics, Inc. (Nasdaq: HARP), a clinical-stage immunotherapy company developing novel T cell engagers, today reported data from the Phase 1 study of HPN217 in patients with RRMM in an oral presentation at the 65th American Society of Hematology (ASH) Annual Meeting and Exposition in San Diego. Harpoon also announced the selection of 12 mg as the HPN217 RP2D.

Key Points: 
  • Harpoon also announced the selection of 12 mg as the HPN217 RP2D.
  • During the trial, 97 patients with RRMM who had received at least three prior therapies were enrolled across 15 dose escalation cohorts and three expansion regimens.
  • As of the data cut-off of October 17, 2023, the data demonstrated:
    Clinical activity across a wide dose range (2.15 mg to 24 mg).
  • The maximum tolerated dose (MTD) was not reached at the target dose using a step up approach.

Gracell Biotechnologies Announces FDA Clearance of IND Application for Phase 1/2 Clinical Trial of FasTCAR-T GC012F for the Treatment of Refractory Systemic Lupus Erythematosus

Retrieved on: 
Monday, November 27, 2023

SAN DIEGO and SUZHOU, China and SHANGHAI, China, Nov. 27, 2023 (GLOBE NEWSWIRE) -- Gracell Biotechnologies Inc. (“Gracell” or the “Company”, NASDAQ: GRCL), a global clinical-stage biopharmaceutical company dedicated to developing innovative and highly efficacious cell therapies for the treatment of cancer and autoimmune disease, today announced that the U.S. Food and Drug Administration (FDA) has cleared Gracell’s Investigational New Drug (IND) application, allowing the Company to initiate a Phase 1/2 clinical trial of FasTCAR-T GC012F in the United States for the treatment of refractory systemic lupus erythematosus (rSLE).

Key Points: 
  • “We are excited to expand the clinical development of our lead FasTCAR asset, GC012F, for treatment of rSLE in the United States,” said Dr. William Cao, founder, Chairman and Chief Executive Officer of Gracell.
  • “This progress marks the second U.S. IND clearance for GC012F, a notable milestone.
  • Systemic lupus erythematosus (SLE) is a B-cell-mediated autoimmune disease, in which autoantibodies produced by the immune system attack the patient’s own tissues, causing multi-organ damage.
  • Further, in preclinical studies, GC012F has shown a more effective elimination of antibody secreting cells compared to CD19 single-targeted CAR-T therapy.

Harpoon Therapeutics Reports Third Quarter 2023 Financial Results and Provides Corporate Update

Retrieved on: 
Thursday, November 9, 2023

SOUTH SAN FRANCISCO, Calif., Nov. 09, 2023 (GLOBE NEWSWIRE) -- Harpoon Therapeutics, Inc. (NASDAQ: HARP) (the “Company”), a clinical-stage immunotherapy company developing novel T cell engagers, today reported financial results for the third quarter ended September 30, 2023 and provided corporate updates.

Key Points: 
  • SOUTH SAN FRANCISCO, Calif., Nov. 09, 2023 (GLOBE NEWSWIRE) -- Harpoon Therapeutics, Inc. (NASDAQ: HARP) (the “Company”), a clinical-stage immunotherapy company developing novel T cell engagers, today reported financial results for the third quarter ended September 30, 2023 and provided corporate updates.
  • Harpoon ended the third quarter of 2023 with $31.6 million in cash, cash equivalents, short-term marketable securities, compared to $53.1 million as of December 31, 2022.
  • Revenue for the third quarter ended September 30, 2023 was $4.5 million, compared to $13.6 million for the third quarter ended September 30, 2022.
  • Research and development (R&D) expense for the third quarter ended September 30, 2023 was $12.3 million, compared to $21.0 million for the third quarter ended September 30, 2022.

Bristol Myers Squibb Announces Data at ASH 2023 from Diverse Multiple Myeloma Pipeline, Underscoring Range of Tailored Treatment Approaches to Address Unique Patient Needs

Retrieved on: 
Tuesday, December 12, 2023

Bristol Myers Squibb (NYSE: BMY) today announced updated results from three key programs within its broad multiple myeloma research pipeline, highlighting its diverse targets and molecular approaches to address unique patient needs within the disease.

Key Points: 
  • Bristol Myers Squibb (NYSE: BMY) today announced updated results from three key programs within its broad multiple myeloma research pipeline, highlighting its diverse targets and molecular approaches to address unique patient needs within the disease.
  • These data were presented at the 65th American Society of Hematology (ASH) Annual Meeting and Exposition in San Diego, California.
  • While multiple myeloma remains a relentless disease, we continue to transform the multiple myeloma treatment paradigm by dramatically improving outcomes for every patient.
  • As a leader in cancer care, Bristol Myers Squibb is working to empower all people with cancer to have a better future.

European Commission Approves Pfizer’s ELREXFIO® for Relapsed and Refractory Multiple Myeloma

Retrieved on: 
Friday, December 8, 2023

Pfizer Inc. (NYSE:PFE) today announced the European Commission (EC) has granted conditional marketing authorization for ELREXFIO® (elranatamab).

Key Points: 
  • Pfizer Inc. (NYSE:PFE) today announced the European Commission (EC) has granted conditional marketing authorization for ELREXFIO® (elranatamab).
  • "More than 50,000 Europeans are diagnosed with multiple myeloma each year, and too often, they face relapse and treatment resistance,” said Chris Boshoff, Chief Oncology Research and Development Officer and Executive Vice President, Pfizer.
  • The conditional marketing authorization for ELREXFIO is valid in all 27 EU member states as well as Iceland, Liechtenstein, and Norway.
  • This authorization follows the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) recommendation for a conditional marketing authorization on October 12, 2023.