STRO-001 receives orphan designation for MM

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Micrograph showing MM
The U.S. Food and Drug Administration (FDA) has granted orphan designation to STRO-001 for the treatment of multiple myeloma (MM). STRO-001 is an antibody-drug conjugate targeting CD74, a protein highly expressed in MM and other B-cell malignancies. Sutro Biopharma, Inc., is currently studying STRO-001 in a phase 1 trial enrolling separate dose-escalation... [Read Article]
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Selinexor receives priority review for penta-refractory MM

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Micrograph showing MM
The U.S. Food and Drug Administration (FDA) has accepted for priority review the new drug application (NDA) for selinexor. With this NDA, Karyopharm Therapeutics Inc., is seeking accelerated approval for selinexor, an oral selective inhibitor of nuclear export compound, as a treatment for penta-refractory multiple myeloma (MM). The FDA grants priority... [Read Article]
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Carfilzomib receives approval for once-weekly dosing

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Carfilzomib (Kyprolis)
Photo courtesy of Amgen
The U.S. Food and Drug Administration (FDA) has approved carfilzomib (Kyprolis) for a once-weekly dosing option in combination with dexamethasone for patients with relapsed or refractory multiple myeloma (MM). Carfilzomib administered once-weekly at 70 mg/m2 with dexamethasone achieved a superior progression-free survival (PFS) and overall response rates (ORR) compared... [Read Article]
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First NGS assay approved for MRD detection in ALL or MM

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Bone marrow aspirate
Photo by Chad McNeeley
The U.S. Food and Drug Administration has authorized the first next-generation sequencing (NGS)-based assay to be marketed for minimal residual disease (MRD) testing in patients with acute lymphoblastic leukemia (ALL) or multiple myeloma (MM). The assay, called clonoSEQ®, uses both polymerase chain reaction (PCR) and NGS to... [Read Article]
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CHMP backs proposed biosimilars of pegfilgrastim

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Neulasta Onpro Kit
Photo from Amgen
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended approval for three proposed biosimilars of pegfilgrastim—Ziextenzo, Pelmeg, and Fulphila. If approved by the European Commission (EC), these products would be used for the same indication as the reference medicine, Neulasta (pegfilgrastim). Neulasta has been... [Read Article]
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AKT inhibitor exhibits activity against MM

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Micrograph showing MM
Preclinical research suggests an AKT inhibitor could be effective against multiple myeloma (MM). The inhibitor, HS1793, is a derivative of the antioxidant compound resveratrol. Investigators found that HS1793 decreased AKT signaling to induce mitochondria-mediated cell death in MM cells. HS1793 was cytotoxic to MM cells in a mouse model of human metastatic... [Read Article]
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ASCO addresses financial barriers to cancer clinical trials

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Preparing drug for a trial
Photo by Esther Dyson
The American Society of Clinical Oncology (ASCO) has issued a policy statement addressing financial barriers to patient participation in cancer clinical trials. ASCO’s policy statement outlines a series of recommendations designed to address multiple financial barriers that impede access to clinical trials, including patient costs that... [Read Article]
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Doc reports ‘very encouraging’ results in penta-refractory MM

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Vials of drugs
Photo by Bill Branson
Treatment with selinexor and low-dose dexamethasone can provide a “meaningful clinical benefit” in patients with penta-refractory multiple myeloma (MM), according to the principal investigator of the STORM trial. Updated results from this phase 2 trial showed that selinexor and low-dose dexamethasone produced an overall response rate of... [Read Article]
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CAR T-cell therapy elicits responses in MM

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Micrograph showing
multiple myeloma
Early results from a phase 1 trial suggest the chimeric antigen receptor (CAR) T-cell therapy P-BCMA-101 can produce responses in patients with relapsed/refractory multiple myeloma (MM). All 11 patients treated have experienced some clinical response, with 8 patients achieving a partial response (PR) or better. The most common adverse events... [Read Article]
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New guidelines on antimicrobial prophylaxis

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Cancer patient
receiving treatment
Photo by Rhoda Baer
Experts have published updated guidelines on antimicrobial prophylaxis for adults with cancer-related immunosuppression. The guidelines include antibacterial, antifungal, and antiviral prophylaxis recommendations, along with additional precautions, such as hand hygiene, that may reduce infection risk. The guidelines were developed by the American Society of Clinical Oncology (ASCO)... [Read Article]
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Daratumumab approved for new indication in MM

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Daratumumab (Darzalex)
Photo courtesy of Janssen
The European Commission (EC) has approved a new indication for daratumumab (Darzalex®). The drug is now authorized for use in combination with bortezomib, melphalan, and prednisone (VMP) to treat adults with newly diagnosed multiple myeloma (MM) who are ineligible for autologous stem cell transplant. Daratumumab was previously approved... [Read Article]
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