Tumor shrinkage was induced in women with ER-positive metastatic breast cancer who had progressed on standard anti-estrogen therapies with treatment with Z-endoxifen, a potent derivative of the drug tamoxifen.
A supplemental new drug application for bosutinib (Bosulif) has been granted a priority review by the FDA for the first-line treatment of patients with Philadelphia chromosome-positive chronic myeloid leukemia. The agency is scheduled to make a final decision by December 2017.<br />
Overall survival was improved for women with cervical cancer by adding bevacizumab (Avastin) to chemotherapy, according to final results from the phase III GOG 240 trial published online in <em>The Lancet</em>.
The FDA has granted breakthrough therapy designation to the investigational HER2-targeting antibody-drug conjugate DS-8201 for the treatment of patients with HER2-positive, locally advanced, or metastatic breast cancer who have been treated with trastuzumab (Herceptin) and pertuzumab (Perjeta) and have disease progression after ado-trastuzumab emtansine (T-DM1; Kadcyla).
A supplemental biologics license application for obinutuzumab (Gazyva) in combination with chemotherapy, followed by obinutuzumab alone, has been granted a priority review by the FDA for the first-line treatment of patients with follicular lymphoma.
Results from a recent retrospective study published in the<em> Journal of Clinical Oncology</em><sup> </sup>revealed hospice enrollment is low and use of aggressive treatment is high for elderly patients with acute myeloid leukemia.
According to results from a trial conducted by investigators from the Children’s Oncology Group, treatment with arsenic trioxide consolidation was effective and safe in newly diagnosed pediatric patients with acute promyelocytic leukemia, allowing a significant reduction in cumulative anthracycline doses.
Carfilzomib (Kyprolis) reduced the risk of death by 21% compared with bortezomib (Velcade) in patients with relapsed/refractory multiple myeloma, according to results from the phase III ENDEAVOR trial, now published in the<em> Lancet Oncology.</em>
Patients with intermediate- or high-risk gastrointestinal stromal tumors were less likely to experience recurrence after 5 years of treatment with imatinib, according to results from the phase II PERSIST-5 trial.
A supplemental biologics license application (sBLA) for brentuximab vedotin (Adcetris) has been granted a priority review by the FDA for the treatment of patients with cutaneous T-cell lymphoma (CTCL), according to Seattle Genetics, which codevelops the antibody-drug conjugate with Takeda.
The risk of progression or death was reduced by 70% with maintenance olaparib (Lynparza) compared with placebo for patients with platinum-sensitive, relapsed, <em>BRCA</em>-mutant ovarian cancer.
According to findings recently published online in the<em> Journal of Clinical Oncology, </em>12<em> </em>weeks of neoadjuvant T-DM1 (ado-trastuzumab emtansine; Kadcyla) with or without endocrine therapy induced superior pathologic complete response (pCR) compared with trastuzumab (Herceptin) plus endocrine therapy in patients with HER2-positive/HR-positive early breast cancer.
Supplemental New Drug Applications were recently submitted in the United States and Europe for carfilzomib (Kyprolis). The sNDAs were submitted based on data from 2 phase III studies showing carfilzomib improves overall survival for patients with relapsed/refractory multiple myeloma.
A supplemental new drug application (sNDA) for alectinib (Alecensa) has been granted a priority review by the FDA for the frontline treatment of patients with <em>ALK</em>-positive locally advanced or metastatic non–small cell lung cancer (NSCLC), according to Genentech (Roche), the manufacturer of the second-generation ALK inhibitor.
A new drug application (NDA) for acalabrutinib has been granted a priority review by the FDA for patients with previously-treated mantle cell lymphoma (MCL), according to AstraZeneca, the manufacturer of the highly selective, potent BTK inhibitor.
Acalabrutinib has been granted a breakthrough therapy designation by the FDA for patients with previously-treated mantle cell lymphoma (MCL), according to AstraZeneca, the manufacturer of the highly selective, potent BTK inhibitor.
A Marketing Authorization Application (MAA) has been submitted to the European Medicines Agency (EMA) for axicabtagene ciloleucel (axi-cel) to treat 3 forms of non-Hodgkin lymphoma (NHL), Kite Pharma has announced.
Women with node-positive stage IB-IIB cervical cancer who received systemic chemotherapy post-surgery were at a reduced risk of distant recurrence, according to results from a retrospective study of Japanese women published in the <em>International Journal of Cancer</em>.
Nivolumab (Opdivo) demonstrated clinical activity in women with recurrent/metastatic cervical cancer, and was active to a lesser extent in vaginal and vulvar cancers, according to phase I/II results from CheckMate-358.
Durvalumab (Imfinzi) has been granted a breakthrough therapy designation by the FDA to treat patients with locally-advanced, unresectable non-small cell lung cancer (NSCLC) whose disease has not progressed following platinum-based chemoradiation.
The use of fulvestrant (Faslodex) to treat estrogen receptor (ER)-positive, locally-advanced or metastatic breast cancer in postmenopausal women not previously treated with endocrine therapy has been approved by the European Commission (EC).
Progression-free survival (PFS) was not improved with frontline durvalumab (Imfinzi), either in combination with tremelimumab or as a single agent, in patients with stage IV metastatic non–small cell lung cancer (NSCLC), compared with standard platinum-based chemotherapy.
Supplemental Biologics License Applications (sBLAs) were sent to and accepted by the FDA for a new dosing schedule for nivolumab (Opdivo) across all of the agent's indications as a montherapy, according to Bristol-Myers Squibb (BMS), the manufacturer of the PD-1 inhibitor.
Midostaurin (Rydapt) has been recommended for approval by the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) to treat adults with newly diagnosed acute myeloid leukemia (AML) who are FLT3 mutation–positive.
Avelumab (Bavencio) has been recommended for approval by the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) for adults with metastatic Merkel cell carcinoma, according to Pfizer and Merck, the codevelopers of the PD-L1 inhibitor.
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has given its support on indications for atezolizumab (Tecentriq) in non–small cell lung cancer (NSCLC) and urothelial carcinoma.
MYL-1401O, the trastuzumab (Herceptin) biosimilar manufactured by Mylan Pharmaceuticals, has been recommended for approval by the FDA's Oncologic Drugs Advisory Committee (ODAC) in a 16-0 vote.
In a 17-0 vote, the FDA’s Oncologic Drugs Advisory Committee unanimously recommended the approval of ABP-215, a biosimilar for bevacizumab.
The Oncologic Drugs Advisory Committee voted 10-0 today to recommend approval of a biologics license application for tisagenlecleucel for the treatment of patients aged 25 or younger with relapsed/refractory B-cell acute lymphoblastic leukemia.
A supplemental new drug application for dasatinib (Sprycel) for use in children with Philadelphia chromosome-positive chronic phase chronic myeloid leukemia has been accepted by the FDA.