Xpovio (selinexor) combined with Kyprolis (carfilzomib) and low-dose dexamethasone leads to strong and durable responses in heavily pretreated multiple myeloma patients, results from a Phase 1/2b trial show. The study, “Once weekly selinexor, carfilzomib and dexamethasone in carfilzomib non-refractory multiple myeloma patients,” was published in the British Journal of Cancer. Xpovio, developed by Karyopharm Therapeutics, is…
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Cancer, also called malignancy, is an abnormal growth of cells with the potential to invade or spread to surrounding tissues and structures found within the body. There are more than 100 types of cancer. A few examples include breast cancer, skin cancer, lung cancer, colon cancer, prostate cancer, and lymphoma. According to the American Cancer Society, 4 out of 10 people will be diagnosed with some form of cancer in their lifetime. Cancer prevalence has given rise to multiple medical specialties focused on symptom management and disease management. Current treatment options depending on the form of cancer include chemotherapy, radiation, blood or bone marrow transfusions, and/or surgery. Lifetime prognosis of cancer mortality is dependent on the type of cancer and is heavily conditional to early detection.
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Immune Therapy AO-176 Awarded FDA’s Orphan Drug Designation
The U.S. Food and Drug Administration (FDA) has granted orphan drug status to Arch Oncology‘s experimental immune-modulating therapy AO-176 as a potential treatment for relapsed or refractory multiple myeloma. This designation, given to therapies with the potential to improve care for conditions that affect fewer than 200,000 people in the U.S., qualifies Arch, as the…
Riney Foundation’s $40M Gift to Further Research at Dana-Farber
The Paula and Rodger Riney Foundation continues to support the Dana-Farber Cancer Institute in its efforts to advance multiple myeloma research, this time with a $40 million grant. This gift — the largest single award to myeloma research in Dana-Farber’s history — brings the foundation’s donations to the institute to nearly $60 million. “The path to…
Japan OKs Abecma as 1st CAR T-cell for Heavily Treated Myeloma
Japan’s Ministry of Health, Labour, and Welfare has approved Abecma (idecabtagene vicleucel) as its first CAR T-cell therapy for adults with relapsed or refractory multiple myeloma who received at least three prior therapies. This includes patients treated at least with one immunomodulatory drug (IMiD), one proteasome inhibitor (PI), and one CD38 inhibitor, and whose disease failed to…
Model May Better Classify Multiple Myeloma and Relapse Risks
A model that may better classify multiple myeloma (MM) using genetic sequence data from hundreds of patients has been developed. The model can identify specific genes and genetic alterations responsible for disease subtypes related to a risk of relapse, and it may contribute to the identification of targeted therapies, according to the study’s researchers, led…
Janssen Seeks FDA Approval of Teclistamab for RRMM
Janssen is seeking the approval of its investigational therapy teclistamab in the U.S. for people with relapsed or refractory multiple myeloma (RRMM). “Despite all the gains that have been made in treating multiple myeloma, the unmet need still remains very high,” Peter Lebowitz, MD, PhD, global therapeutic area head of oncology at Janssen research and…
Xpovio Conditionally Approved in China for Heavily Treated Patients
China’s National Medical Products Administration (NMPA) has conditionally approved a combination of Xpovio (selinexor) and the corticosteroid dexamethasone to treat adults with relapsed or refractory multiple myeloma (RRMM) who received at least three prior therapies. This includes patients whose disease failed to respond to at least one immunomodulatory agent (IMiD), one proteasome inhibitor (PI), and…
Cilta-cel Approval Requested in Japan for Heavily-treated Myeloma
Janssen has submitted an application to regulators in Japan seeking the approval of ciltacabtagene autoleucel, an investigational CAR T-cell therapy also known as cilta-cel, to treat relapsed or refractory multiple myeloma patients. The submission to the Japanese Ministry of Health, Labour and Welfare (MHLW) specifically asks that cilta-cel be approval for patients who received at…
FDA Approves 8th Darzalex Faspro Indication for Myeloma Patients
The U.S. Food and Drug Administration (FDA) has approved Darzalex Faspro (daratumumab and hyaluronidase), in combination with Kyprolis (carfilzomib) and the corticosteroid dexamethasone, for the treatment of adults with multiple myeloma who have received one to three lines of therapy. Darzalex Faspro is a subcutaneous, or under-the-skin, formulation of the Janssen laboratory-made therapy Darzalex (daratumumab),…
GC012F, CAR-T Cell Therapy Candidate, Granted FDA Orphan Drug Status
Gracell Biotechnologies’ investigational new treatment for multiple myeloma, GC012F, has been named an orphan drug by the U.S. Food and Drug Administration (FDA). Orphan drug status is intended to encourage the development of therapies for rare diseases affecting fewer than 200,000 people in the U.S. It provides benefits and incentives, including exemption from FDA application…
1st Patient Enrolled in Phase 1 Trial of Antibody Therapy BHV-1100
Biohaven Pharmaceuticals has begun enrolling patients in its Phase 1a/1b trial testing the company’s antibody-recruiting molecule (ARM) called BHV-1100. The trial (NCT04634435) seeks to recruit 25 adults with newly diagnosed multiple myeloma who have minimal residual disease in first remission before a stem cell transplant. One patient has now been enrolled. The trial will assess…
Optimal Dose of Tasquinimod Found in First Phase of RRMM Trial
The optimal dosing of tasquinimod, Active Biotech’s experimental oral therapy for adults with relapsed or refractory multiple myeloma, has been determined in a Phase 1b/2a clinical trial. Now, that dose and schedule will be tested, along with the standard oral combination treatment, in the trial’s second phase, the company said in a press release. “We…