Tecentriq (atezolizumab), in combination with Avastin (bevacizumab), has been recommended for approval in the European Union as a first-line treatment for adults with advanced hepatocellular carcinoma (HCC), the most common form of liver cancer. The recommendation was made by the Committee for Medicinal Products for Human Use (CHMP), an arm of the European Medicines Agency. The…
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
Phase 1 Trial of Oral Treatment for Metastatic CRPC Doses First Patient
A first patient has been dosed in a Phase 1 clinical trial investigating the small molecule inhibitor EPI-7386 as a treatment for metastatic castration-resistant prostate cancer (CRPC), its developer, ESSA Pharma, reported. Metastatic CRPC is prostate cancer that has metastasized, or spread to distant regions, and is resistant to traditional treatments that lower levels of androgen hormones,…
Lynparza Combo Recommended by EU Committee as First-line Maintenance for Advanced Ovarian Cancer
Lynparza (olaparib), in combination with bevacizumab, has been recommended for approval in the European Union (EU) as a first-line maintenance therapy for women with advanced ovarian cancer positive for homologous recombination deficiency (HRD) and who responded to platinum-based chemotherapy. The positive opinion released by the Committee for Medicinal Products for Human Use (CHMP), an arm of the European Medicines Agency, also includes…
Clinical Trial Testing Estrogen Receptor Degrader GDC-9545 Enrolls First Participant
The first participant has been enrolled in a Phase 2 clinical trial evaluating the safety and efficacy of GDC-9545 in combination with palbociclib as an investigational treatment for postmenopausal women with estrogen receptor (ER)-positive and HER2-negative untreated early breast cancer. “The initiation of enrolment is an important milestone as we aim to better understand the activity and safety of this…
Ide-cel Granted FDA Priority Review for Heavily-treated Multiple Myeloma
The U.S. Food and Drug Administration (FDA) has granted priority review to Bristol Myers Squibb and Bluebird Bio‘s application requesting the approval of idecabtagene vicleucel (ide-cel) for the treatment of adults with multiple myeloma. The biologics license application (BLA), resubmitted in August, is seeking ide-cel’s approval for myeloma patients who failed to respond to at least three prior lines…
EU Approval Recommended for Opdivo-Yervoy-Chemo Combo for Advanced NSCLC
A European Medicines Agency (EMA) committee has recommended that a combination therapy of Opdivo (nivolumab) and Yervoy (ipilimumab) plus two cycles of platinum-based chemotherapy be approved in the European Union (EU) as first-line treatment for advanced non-small cell lung cancer (NSCLC). The EMA’s Committee for Medicinal Products for Human Use (CHMP) recommended the approval specifically for adults whose tumors contain no mutations in the…
Lynparza’s Approval Favored in EU for mCRPC Patients with BRCA Mutations
Lynparza (olaparib) has been recommended for approval in the European Union to treat men with metastatic castration-resistant prostate cancer (mCRPC) who carry mutations in BRCA1 and BRCA2, two DNA repair genes. The marketing authorization application is specific for men whose disease progressed after treatment that included a newer hormone therapy, such as Xtandi (enzalutamide) or Zytiga (abiraterone acetate). The positive opinion by the…
CHMP Favors Zejula as First-line Maintenance Therapy for Platinum-sensitive Advanced Ovarian Cancer
The Committee for Medicinal Products for Human Use (CHMP) has recommended Zejula (niraparib) as a first-line maintenance therapy for women with advanced ovarian cancer who responded to platinum-based chemotherapy. This favorable opinion by the committee, a branch of the European Medicines Agency (EMA), is one of the final steps of Zejula’s marketing authorization procedure that may lead to…
FDA Grants Fast Track Designation to ‘Off-the-shelf’ CAR T-cell Therapy
The U.S. Food and Drug Administration has granted fast track designation to PBCAR269A, Precision BioSciences‘ donor-derived CAR T-cell therapy for the treatment of relapsed or refractory multiple myeloma. Fast track status is meant to facilitate the development, and accelerate the review, of new medications that aim to treat serious conditions and fill an unmet medical need.…
FDA Acts to Speed Toripalimab as Potential Nasopharyngeal Cancer Treatment
The U.S. Food and Drug Administration (FDA) has designated toripalimab (JS001) a breakthrough therapy as a potential treatment of nasopharyngeal carcinoma (NPC), one of the most common cancers in China and one lacking treatment options elsewhere. This designation is given to medications for serious or life-threatening conditions that have the potential to provide significant advantages over current alternatives, and…
Phase 1 Trial Begins Dosing Patients With Investigational Brain-penetrant HER2 Inhibitor
Patient dosing has begun in Zion Pharma‘s Phase 1 clinical trial in the United States to evaluate the safety of its investigational HER2 inhibitor, ZN-A-1041, in people with HER2-positive breast cancer and other solid tumors. “We are excited to have initiated our Phase 1 trial for ZN-A-1041,” Zack Cheng, PhD, chairman, CEO, and co-founder of…
EMA to Review Opdivo-Yervoy Combo for Untreated, Inoperable Mesothelioma
The European Medicines Agency has agreed to review Bristol Myers Squibb’s application requesting approval for the dual immunotherapy regimen Opdivo (nivolumab) and Yervoy (ipilimumab) for untreated, inoperable malignant pleural mesothelioma (MPM). This decision comes after promising data from the Phase 3 CheckMate-743 trial (NCT02899299), in which the immunotherapy combo prolonged patients’ lives from a median of 14.1 months…