Jason M. Broderick

According to findings from the phase III ATLAS trial, disease-free survival was not extended with adjuvant axitinib (Inlyta) versus placebo for patients at high risk of recurrent renal cell carcinoma after nephrectomy.

A new drug application seeking a full approval for duvelisib for the treatment of patients with relapsed/refractory chronic lymphocytic leukemia/small lymphocytic lymphoma and an accelerated approval for the treatment of patients with relapsed/refractory follicular lymphoma has been granted a priority review by the FDA.

Based on findings from the phase III ARIEL3 trial, rucaparib (Rubraca) tablets have been approved by the FDA for use as a maintenance treatment for patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy, according to Clovis Oncology, the manufacturer of the PARP inhibitor.

According to findings from the phase III ECHO-301/KEYNOTE-252 trial, progression-free survival was not improved with the combination of the PD-1 inhibitor pembrolizumab (Keytruda) and the IDO1 inhibitor epacadostat versus single-agent pembrolizumab in patients with unresectable or metastatic melanoma.

According to Pfizer, manufacturer of a pan-human EGFR tyrosine kinase inhibitor (TKI), a priority review has been granted by the FDA for their TKI inhibitor, dacomitinib, in the frontline setting for patients with&nbsp;<em>EGFR</em>-positive locally advanced or metastatic non&ndash;small cell lung cancer.

Based on data from the phase III 482 study, denosumab (Xgeva) has been approved for an expanded indication by the European Commission&nbsp;for the prevention of skeletal-related events in adult patients with multiple myeloma, according to Amgen, the developer of the RANK ligand inhibitor.

Blinatumomab (Blincyto) has been granted an accelerated approval by the FDA for the&nbsp;treatment of patients with B-cell precursor acute lymphoblastic leukemia who are in remission but still have minimal residual disease.

Based on findings from the phase III ECHELON-1 trial,&nbsp;brentuximab vedotin (Adcetris) has been approved by the FDA for use in&nbsp;combination with chemotherapy as a frontline treatment for adult patients with stage III or IV classical Hodgkin lymphoma,&nbsp;according to a statement from Seattle Genetics, the manufacturer of the CD30-targeted antibody-drug conjugate.

According to topline findings from the phase III IMpower131 trial, the addition of atezolizumab (Tecentriq) to frontline carboplatin and nab-paclitaxel delayed progression or death compared with chemotherapy alone for patients with advanced squamous non&ndash;small cell lung cancer. These results were released by Genentech, the manufacturer of the anti&ndash;PD-L1 agent.

Uttara Nayar, PhD, shares the findings of recent studies in patients with ER+ breast cancer. Findings&nbsp;have shown that acquired HER2 mutations lead to endocrine resistance, the most frequent cause of breast cancer mortality in the country.

External beam radiation therapy can be effective when integrated in a multimodality treatment strategy for patients with relapsed/refractory follicular lymphoma, according to findings from a small, retrospective study.&nbsp;

According to results from the phase III MONALEESA-7 trial presented at the 2018 Miami Breast Cancer Conference, the progression-free survival benefit for ribociclib in pre- or perimenopausal women with hormone receptor&ndash;positive, HER2-negative advanced or metastatic breast cancer had been sustained across patient subgroups.

Based on data&nbsp;from the phase III S-TRAC trial,<span style="font-size:10.8333px"> </span>the&nbsp;European Medicines Agency&rsquo;s Committee for Medicinal Products for Human Use recently recommended against approving&nbsp;sunitinib for use as an adjuvant therapy in patients with renal cell carcinoma who have received nephrectomy and are high risk for recurrence.

The FDA has approved a 4-week dosing schedule for the PD-1 inhibitor nivolumab (Opdivo) across several indications.

Based on data from the phase III MONARCH 3 trial, abemaciclib has been granted FDA approval for use in combination with an aromatase inhibitor for the frontline treatment of postmenopausal women with HR-positive, HER2-negative advanced or metastatic breast cancer,&nbsp;according to Eli Lilly and Company, the manufacturer of the CDK4/6 inhibitor.

In findings from the phase III COLUMBUS trial, the combination of the BRAF inhibitor encorafenib and the MEK inhibitor binimetinib improved survival versus single-agent&nbsp;vemurafenib (Zelboraf) in patients with&nbsp;<em>BRAF</em>-mutant advanced, unresectable or metastatic melanoma.

Based on results from the phase III PACIFIC trial, durvalumab has been granted approval by the FDA&nbsp;for the treatment of patients with locally advanced, unresectable stage III non&ndash;small cell lung cancer who have not progressed following chemoradiotherapy.

Based on results of the phase III SPARTAN trial, apalutamide has been approved by the FDA for the treatment of patients with&nbsp;nonmetastatic castration-resistant prostate cancer, making it the first treatment to be approved in this setting.<br /> &nbsp;

In findings from the phase III SPARTAN trial presented at the 2018 Genitourinary Cancers Symposium and published in the&nbsp;<em>New England Journal of Medicine,&nbsp;</em>apalutamide (Erleada) reduced the risk of metastasis or death by 72% in patients with nonmetastatic castration-resistant prostate cancer.

Based on supporting data from the phase III DUO trial and the phase II DYNAMO study, duvelisib has been submitted to the FDA for a full approval&nbsp;for the treatment of patients with relapsed/refractory chronic lymphocytic leukemia/small lymphocytic lymphoma and an accelerated approval for the treatment of patients with relapsed/refractory follicular lymphoma.

Patients with relapsed/refractory myeloma&nbsp;who had prior exposure to lenalidomide (Revlimid) experienced a significant improvement in&nbsp;progression-free survival with pomalidomide (Pomalyst) added to the combination of bortezomib (Velcade) and low-dose dexamethasone,&nbsp;according to findings from the phase III OPTIMISMM trial.

Based on results of the phase III NETTER-1 trial, Lutathera has been approved by the FDA for the treatment of patients with somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors.

Adjuvant pembrolizumab (Keytruda) reduced the risk of recurrence by 43% in patients with stage III resected high-risk melanoma,&nbsp;according to findings from the phase III EORTC1325/KEYNOTE-054 trial

The FDA has issued its approval for overall survival data from the&nbsp;phase III ENDEAVOR trial to be added&nbsp;to the&nbsp;carfilzomib (Kyprolis) label&nbsp;for use in patients with relapsed or refractory multiple myeloma.

Based on results of the phase II JULIET study,&nbsp;a supplemental biologics license application for the CAR T-cell therapy tisagenlecleucel (Kymriah) has been granted a priority review by the FDA&nbsp;as a treatment for adult patients with relapsed/refractory diffuse large B-cell lymphoma who are ineligible for or relapse after autologous stem cell transplant.

Based on results from the phase III OlympiAD trial, the PARP inhibitor olaparib (Lynparza) has been approved by the FDA&nbsp;for the treatment of patients with germline&nbsp;BRCA-positive, metastatic breast cancer.

Pembrolizumab (Keytruda) has been approved in Japan for the treatment&nbsp;of patients with radically unresectable urothelial carcinoma who progressed after cancer chemotherapy, according to Merck, the manufacturer of the PD-1 inhibitor.

Based on results of the Ib/II Study 111, the combination of the PD-1 inhibitor pembrolizumab and the VEGF/FGF inhibitor lenvatinib has been granted a breakthrough therapy designation by the FDA for the treatment of patients with advanced and/or metastatic renal cell carcinoma.

Based on data from the phase III 482 study, denosumab (Xgeva) has been granted FDA approval for&nbsp;the prevention of skeletal-related events in patients with multiple myeloma, according to Amgen, the developer of the RANK ligand inhibitor.

Based on results of the phase III MONALEESA-7 trial,&nbsp;ribociclib (Kisqali) has been granted a breakthrough therapy designation by the FDA for use in combination with&nbsp;tamoxifen or an aromatase inhibitor as frontline treatment for pre- or perimenopausal women with hormone receptor&ndash;positive, HER2-negative advanced or metastatic breast cancer.