Darzalex Faspro (daratumumab and hyaluronidase) significantly extended the time people with relapsed or refractory multiple myeloma live without disease worsening, when added to a combination of Pomalyst (pomalidomide) and dexamethasone, a Phase 3 clinical trial shows. Darzalex Faspro is a subcutaneous, or under-the-skin, formulation of Janssen‘s Darzalex (daratumumab), which is administered intravenously (into the vein).…
About Cancer
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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Cancer News
Health Canada Approves Opdivo-Yervoy-Chemo Combo for Advanced NSCLC
Health Canada has approved a combination therapy of Opdivo (nivolumab) and Yervoy (ipilimumab) plus two cycles of platinum-based chemotherapy for the treatment of metastatic non-small cell lung cancer (NSCLC). The approval includes patients who have not received any form of systemic therapy for their metastatic disease and whose tumors contain no mutations in the EGFR or…
Tukysa Combo Approved in Australia for Advanced HER2-Positive Breast Cancer
The Australian Therapeutic Goods Administration (TGA) has approved Seattle Genetics’ Tukysa (tucatinib), when given alongside trastuzumab and Xeloda (capecitabine), for the treatment of patients with advanced inoperable or metastatic HER2-positive breast cancer, who received at least one anti-HER2-based treatment for metastatic disease. The approval also includes those in whom cancer has already spread to the brain (brain metastases). With…
XMT-1536 on FDA Fast Track for Platinum-resistant, Advanced Ovarian Cancer
The U.S. Food and Drug Administration (FDA) has given fast track designation to Mersana Therapeutics’ XMT-1536 as a possible treatment for women with platinum-resistant high-grade serous ovarian cancer who received up to three prior lines of therapy. The designation also covers those who were treated with four different systemic therapies, regardless of their platinum-disease status. Fast track is meant to…
HealthTree University Opens to Help Myeloma Patients Better Direct Their Care
The online portal HealthTree has opened a free and online patient resource connecting multiple myeloma experts from around the world with patients to help them better understand their disease, so doctor visits can be better spent on personalized care. More than 120 myeloma specialists are expected to participate in HealthTree University (HTU), which offers a comprehensive curriculum…
Opdivo-Yervoy Combo Prolongs Survival of Patients With Inoperable Mesothelioma, Phase 3 Trial Shows
A dual immunotherapy regimen of Opdivo (nivolumab) and Yervoy (ipilimumab) can prolong the survival of patients with untreated, inoperable malignant pleural mesothelioma (MPM), according to data from a Phase 3 clinical trial. Findings from this study about MPM, a severe form of cancer of the pleura (the protective lining surrounding the lungs), were presented by Bristol…
Dosing Begins in Trial of PET Imaging Agent to Detect Prostate Cancer’s Return
The first patients have been injected in a Phase 3 trial investigating the safety and performance of Blue Earth Diagnostics‘ imaging agent rhPSMA-7.3 (18F) in detecting prostate cancer in men with suspected disease recurrence, the company announced. The SPOTLIGHT trial (NCT04186845) is recruiting patients at several sites in the U.S. and at a single site in Finland.…
Partnership Improves Patient Access to Apealea Outside US
Elevar Therapeutics and Tanner Pharma Group have partnered to make Apealea (paclitaxel micellar) accessible in areas outside the U.S. where the medication is not available. The companies have created a global named patient program, also known as an early or expanded access program, which provides physicians with a framework to legally and ethically prescribe investigational…
FDA Will Review Two New Applications Seeking Keytruda Approval for TNBC
The U.S. Food and Drug Administration (FDA) has accepted to review two new Merck applications requesting the approval of Keytruda (pembrolizumab) for the treatment of patients with different forms of triple-negative breast cancer (TNBC). One of the two supplemental biologics license applications (sBLAs) was granted priority review, which speeds FDA action, with a Prescription Drug User…
Ide-cel Application Resubmitted to FDA With Requested Data
Bristol Myers Squibb and Bluebird Bio have resubmitted a biologics license application (BLA) with additional information requested by the U.S. Food and Drug Administration to consider the approval of idecabtagene vicleucel (ide-cel) for adults with hard-to-treat multiple myeloma. According to a press release, the BLA now includes further details on the CAR T-cell therapy’s chemistry, manufacturing, and control — a module necessary to…
FDA Approves Blenrep, 1st of Its Kind, for Heavily Pretreated Multiple Myeloma
The U.S. Food and Drug Administration (FDA) has granted accelerated approval to Blenrep (belantamab mafodotin-blmf), a first-in-class treatment for heavily pretreated adults with relapsed or refractory multiple myeloma, its developer, GlaxoSmithKline, announced. The approval is specific for people who have been given at least four previous therapies, including a CD38 inhibitor, a proteasome inhibitor, and an immunomodulatory…
FDA Clears FT819 CAR T-cell Therapy for Clinical Testing in Lymphoma, Leukemia
Fate Therapeutics will soon initiate a Phase 1 trial investigating its CAR T-cell therapy, FT819, across several B-cell cancers, including chronic lymphocytic leukemia (CLL), acute lymphoblastic leukemia (ALL), and non-Hodgkin’s lymphoma (NHL). The announcement follows the clearance of Fate’s investigational new drug (IND) application by the U.S. Food and Drug Administration (FDA). The trial will…