Jason Harris

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 /> &nbsp;

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>^&nbsp;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&rsquo;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>&nbsp;</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. &nbsp;

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&ndash;small cell lung cancer (NSCLC), according to Genentech (Roche), the manufacturer of the second-generation&nbsp;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&nbsp;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,&nbsp;in patients with stage IV metastatic non&ndash;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&#39;s indications as a montherapy, according to Bristol-Myers Squibb (BMS), the manufacturer of the PD-1 inhibitor.&nbsp;

Midostaurin (Rydapt) has been recommended for approval by the European Medicines Agency&#39;s Committee for Medicinal Products for Human Use (CHMP) to treat adults with newly diagnosed acute myeloid leukemia (AML) who are FLT3 mutation&ndash;positive.

Avelumab (Bavencio) has been recommended for approval by the European Medicines Agency&#39;s&nbsp;Committee for Medicinal Products for Human Use (CHMP)&nbsp;for adults with metastatic Merkel cell carcinoma, according to Pfizer and Merck, the codevelopers of the PD-L1 inhibitor.

The European Medicines Agency&rsquo;s Committee for Medicinal Products for Human Use (CHMP) has given its support on indications for atezolizumab (Tecentriq) in non&ndash;small cell lung cancer (NSCLC) and urothelial carcinoma.&nbsp;

MYL-1401O, the trastuzumab (Herceptin) biosimilar manufactured by Mylan Pharmaceuticals, has been recommended for approval by the FDA&#39;s&nbsp;Oncologic Drugs Advisory Committee (ODAC) in a 16-0 vote.

In a 17-0 vote, the FDA&rsquo;s Oncologic Drugs Advisory Committee&nbsp;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.