RRMM

Pfizer Highlights Progress in Accelerating Breakthrough Cancer Medicines at ASCO 2024 Annual Meeting

Retrieved on: 
Monday, April 29, 2024
Research, FDA, Clinical Trials, Biotechnology, General Health, Pharmaceutical, Health, Science, Oncology, Other Science, PFS, Brentuximab vedotin, Triple-negative breast cancer, Lung cancer, MBC, ASCO, Lymphoma, PFE, Metastasis, ALK, Breast cancer, Learning, CRS, Food, Colorectal cancer, Abstract, RRMM, Rituximab, ADC, HR, CDK4, De novo, Spacecraft, DLBCL, Tucatinib, Anaplastic lymphoma kinase, Safety, Crizotinib, Pembrolizumab, Survival, EZH2, Pros, Inc., Neoplasm, Progression-free survival, Recurrence, PAL, Biologics license application, HRR, Hodgkin lymphoma, Patient, Society, Cyclin-dependent kinase 4, Cytokine release syndrome, Annual general meeting, APLS, PBC, Lenalidomide, B-cell lymphoma, Pharmaceutical industry

Pfizer Inc. (NYSE: PFE) highlights its progress in advancing new potential standards of care in Oncology at the 2024 American Society of Clinical Oncology (ASCO®) Annual Meeting, taking place May 31 to June 4 in Chicago.

Key Points: 
  • Pfizer Inc. (NYSE: PFE) highlights its progress in advancing new potential standards of care in Oncology at the 2024 American Society of Clinical Oncology (ASCO®) Annual Meeting, taking place May 31 to June 4 in Chicago.
  • “We are excited to participate in our first ASCO Annual Meeting following the creation of Pfizer’s new Oncology organization, where we will highlight our efforts to accelerate breakthrough medicines that help people with cancer live better and longer lives,” said Chris Boshoff, Chief Oncology Officer and Executive Vice President, Pfizer.
  • An oral presentation on extended duration of response from the Phase 3 MOUNTAINEER trial adds to the positive profile of TUKYSA in colorectal cancer.
  • Those interested in learning more can visit www.Pfizer.com/apls to access the summaries starting Friday, May 24.

EQS-News: Heidelberg Pharma granted orphan drug designation by FDA for its proprietary ATAC candidate HDP-101

Retrieved on: 
Wednesday, April 10, 2024
ODD, Diagnosis, RRMM, BCMA, Patient, Multiple myeloma, Spacecraft, Amanitin, AACR, Antibody, Safety, HPHA, FDA, B-cell maturation antigen, ATAC, Food, Pharmaceutical industry

Ladenburg, Germany, 27 March 2024 – Heidelberg Pharma AG (FSE: HPHA), a clinical stage biotech company developing innovative Antibody Drug Conjugates (ADCs), is pleased to announce that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) for the treatment of multiple myeloma to its lead candidate HDP-101.

Key Points: 
  • Ladenburg, Germany, 27 March 2024 – Heidelberg Pharma AG (FSE: HPHA), a clinical stage biotech company developing innovative Antibody Drug Conjugates (ADCs), is pleased to announce that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) for the treatment of multiple myeloma to its lead candidate HDP-101.
  • Heidelberg Pharma is investigating the candidate in a clinical Phase I/IIa study for the treatment of relapsed/refractory multiple myeloma (RRMM).
  • Prof. Dr. Andreas Pahl, Chief Executive Officer at Heidelberg Pharma, commented: “We are delighted that our proprietary ATAC candidate HDP-101 has been granted Orphan Drug Designation by the FDA, providing further validation of its potential benefit as a therapeutic for patients with multiple myeloma.
  • The designation provides significant incentives to promote the development of the drug including tax credits for qualified clinical trials, prescription drug user-fee exemptions, and potential seven-year marketing exclusivity upon FDA approval.

Florida Cancer Specialists & Research Institute Shares Pharmacy Expertise To Advance Medically Integrated Oncology Care

Retrieved on: 
Wednesday, April 3, 2024
Real-World Evidence, RN, Success, BP, RRMM, Doctor of Pharmacy, BCPS, Selinexor, Incidence, Partnership, Physician, Manufacturing, Bachelor of Pharmacy, DNP, Nursing, Prior authorization, Pharmacist, Roger Hawkins (drummer), CAPM, MPA, BSN, Therapy, RPH, Pharmacy, Outcome, Safety, Infrared spectroscopy correlation table, Best practice, FCS, PACS, OCN, Data, Metric, Health care

FORT MYERS, Fla., April 3, 2024 /PRNewswire/ -- Florida Cancer Specialists & Research Institute, LLC (FCS) leaders and pharmacy experts will share insights and best practices in specialty pharmacy operations and dispensing that are contributing to positive patient outcomes at the NCODA 2024 Spring Forum in Dallas. The focus of the multi-day gathering, "Driving Optimal Strategies for Patient Care in Medically Integrated Oncology," is on the vital role of pharmacy involvement throughout the entire cancer care continuum.

Key Points: 
  • The focus of the multi-day gathering, "Driving Optimal Strategies for Patient Care in Medically Integrated Oncology," is on the vital role of pharmacy involvement throughout the entire cancer care continuum.
  • "Our Rx To Go team members continue to set the standard of excellence for medically-integrated oncology pharmacy and support services," said FCS President & Managing Physician Lucio Gordan, MD .
  • "They are well-equipped to contribute top-tier knowledge to help steer the future of oncology care."
  • NCODA is a globally recognized not-for-profit organization dedicated to building a patient-centered, medically integrated community of health care providers whose focus is to innovate the continuity of cancer care so that every patient receives the maximum benefit from their cancer treatment.

Poseida Therapeutics Announces FDA Orphan Drug Designation Granted to P-BCMA-ALLO1 for the Treatment of Multiple Myeloma

Retrieved on: 
Wednesday, March 13, 2024
Diagnosis, Orphan drug, RRMM, ASH, TSCM, Bone marrow, Partnership, BCMA, Patient, SAN, Food and Drug Administration, Roche, Multiple myeloma, Cancer, AACR, Society, Therapy, FDA, Food, Pharmaceutical industry

SAN DIEGO, March 13, 2024 /PRNewswire/ -- Poseida Therapeutics, Inc. (Nasdaq: PSTX), a clinical-stage cell and gene therapy company advancing a new class of treatments for patients with cancer and rare diseases, today announced the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation for the treatment of multiple myeloma to P-BCMA-ALLO1, a novel BCMA-targeted allogeneic, T stem cell memory (TSCM)-rich chimeric antigen receptor (CAR)-T therapy candidate. The Company is investigating P-BCMA-ALLO1 in partnership with Roche for the treatment of relapsed/refractory multiple myeloma (RRMM).

Key Points: 
  • The Company is investigating P-BCMA-ALLO1 in partnership with Roche for the treatment of relapsed/refractory multiple myeloma (RRMM).
  • "The Orphan Drug Designation for P-BCMA-ALLO1 underscores the high unmet medical need for a rapid and accessible off-the-shelf allogeneic CAR-T therapy for patients with multiple myeloma," said Kristin Yarema, Ph.D., President and Chief Executive Officer of the Company.
  • The FDA's Orphan Drug Designation program provides orphan status to drugs or biologics intended for the prevention, diagnosis, or treatment of diseases that affect fewer than 200,000 people in the United States.
  • Sponsors of medicines that are granted Orphan Drug Designation are entitled to certain incentives, including tax credits for qualified clinical trials, prescription drug user-fee exemptions, and potential seven-year marketing exclusivity upon FDA approval.

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
QW, CD3, RRMM, Physician, FDA, Food, BCMA, Patient, Multiple myeloma, B-cell maturation antigen, Pharmaceutical industry

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
Bone marrow, Health Canada, Multiple myeloma, RRMM, News, Pfizer, B cell, Myeloma Canada, Patient, Disease, Cancer, Pharmaceutical industry

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
Patient, SAN, IIT, Society, Cancer, Autoimmune disease, RRMM, CD19, IND, Food, Multiple myeloma, Safety, FDA, BCMA, Pharmaceutical industry

“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
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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
Autoimmune disease, CDE, SLE, IIT, Trial of the century, BCMA, Society, Cancer, Investigational New Drug, B cell, NMPA, NHL, National Medical Products Administration, RRMM, CD19, Patient, Vaccine

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
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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.