News

A supplemental biologics license application for the frontline combination of atezolizumab plus nab-paclitaxel has been granted a priority review by the FDA for the treatment of patients with unresectable locally advanced or metastatic PD-L1–positive triple-negative breast cancer, based on data from the phase III IMpassion130 trial.

Adding thalidomide to induction and maintenance therapy in stem cell transplant-eligible, newly diagnosed patients with multiple myeloma improved event-free survival and progression-free survival compared with standard chemotherapy drugs and interferon alfa, according to a long-term follow-up analysis from a phase III open-label randomized trial.

Based on data from the phase III SOLO-1 trial, a supplemental new drug application for olaparib tablets has been granted a priority review by the FDA for use as a maintenance therapy in patients with newly-diagnosed,<em>&nbsp;BRCA</em>-positive advanced ovarian cancer who achieved a complete or partial response to standard frontline platinum-based chemotherapy.

Pembrolizumab (Keytruda) has received an accelerated approval from the FDA&nbsp;for the treatment of patients with hepatocellular carcinoma who have previously received sorafenib (Nexavar).

Promising data with PARP inhibitors, specifically olaparib and niraparib, are showcasing this class of agents&rsquo; activity in early and later-line settings of ovarian cancer, explained Kathleen Moore, MD.&nbsp;

A supplemental new drug application (sNDA)&nbsp;for avatrombopag (Doptelet) as a treatment for patients with chronic immune thrombocytopenia (ITP) who have had an inadequate response to prior treatment has been accepted for review by the FDA.

According to topline findings from the phase III TIVO-3 trial,&nbsp;tivozanib (Fotivda) reduced the risk of disease progression or death by 26% compared with sorafenib (Nexavar) in patients with highly refractory advanced or metastatic renal cell carcinoma.

Selinexor has been granted a fast track designation by the FDA for the&nbsp;treatment of patients with previously treated diffuse large B-cell lymphoma who are ineligible to receive high-dose chemotherapy with stem cell rescue or chimeric antigen receptor T-cell therapy.

Combining&nbsp;atezolizumab (Tecentriq) with&nbsp;bevacizumab (Avastin) induced promising and durable antitumor activity in patients with&nbsp;advanced hepatocellular carcinoma, according to findings from a phase Ib study presented during the 2018 ESMO Congress.

Considering data from the real-world setting is becoming increasingly important with the use of anticancer agents, as there is likely a big difference between patients in a clinical trial and patients in the real world, said&nbsp;Juan Manuel O&rsquo;Connor, MD. During the 2018 ESMO Congress, O&#39;Connor presented real-world dosing findings for&nbsp;regorafenib in patients with metastatic colorectal cancer.

According to findings of a systematic literature review presented at the 2018 ESMO Congress, the neoadjuvant and metastatic breast cancer settings are appropriate areas to evaluate&nbsp;the equivalence of biosimilars and originator products.

Based on data from the phase II ELOQUENT-3 trial,&nbsp;elotuzumab (Empliciti) has received approval from the FDA in combination with&nbsp;pomalidomide (Pomalyst) and low-dose dexamethasone for the treatment of patients with relapsed/refractory multiple myeloma following 2 or more prior therapies, including lenalidomide (Revlimid) and a proteasome inhibitor.

The rate of the 3 most common adverse events reported by US patients on niraparib who were started on 200 mg/day in real-world clinical practice is markedly less than the rate of AEs experienced by those enrolled in the pivotal phase III ENGOT-OV6/NOVA trial, in which patients were started at a 300-mg daily dose of niraparib, according to data presented at the 2018 ESMO Congress.

Daniel Petrylak, MD, recently spoke on the treatment considerations and decisions he makes when treating patients with bladder cancer. Petrylak explained his treatment decisions based on 2 case scenarios during a <em>Targeted Oncology </em>live case-based peer perspectives presentation.

Based on findings from the phase III ECHELON-2 trial, brentuximab vedotin (Adcetris) has been submitted to the FDA for approval&nbsp;in combination with chemotherapy for the frontline treatment of patients with CD30-expressing peripheral T-cell lymphoma.

Pegfilgrastim-cbqv (CHS-1701; Udencya), a pegfilgrastim (Neulasta) biosimilar, has been granted approval by the FDA&nbsp;for patients with cancer receiving myelosuppressive chemotherapy.

Lurbinectedin did not improve progression-free survival over pegylated liposomal doxorubicin or topotecan in patients with platinum-resistant ovarian cancer, according to results of the phase III CORAIL trial.

Gilberto Lopes, MD,&nbsp;discusses findings from the phase III KEYNOTE-042 trial and ongoing developments with immunotherapy in NSCLC.

Joseph A. Sparano, MD,&nbsp;the current role of liquid biopsy and the ongoing challenge of improving survival for patients with metastatic disease.

According to first-in-human findings reported in a poster presentation during the ESMO Annual Congress, genetically engineered&nbsp;T-cells targeting melanoma-associated antigen-A4 appeared safe and demonstrated some evidence of&nbsp;antitumor activity.

Lorlatinib (Lorbrena) has been granted an accelerated approval by the FDA for use in patients with&nbsp;<em>ALK</em>-positive metastatic non&ndash;small cell lung cancer who have progressed on 1 or more ALK tyrosine kinases inhibitors.

Milind Javle, MD, discusses findings with the selective pan-FGFR kinase infigratinib in patients with intrahepatic cholangiocarcinoma and how they highlight&nbsp;the role of molecular profiling.

A look back at all the&nbsp;FDA news&nbsp;that happened in the month of&nbsp;October 2018, including several new FDA approvals, priority reviews, a breakthrough therapy designation, and more, in a variety of cancer types.<br /> &nbsp;

Igor Puzanov, MD, MSCI, FACP, discusses the current and potential future utility of T-VEC in patients with advanced-stage melanoma.

Treatment-na&iuml;ve patients with chronic lymphocytic leukemia who had comorbidities saw a reduction in the risk of disease progression or death after treatment with venetoclax combined with obinutuzumab versus obinutuzumab plus chlorambucil.

Simon Rule, MD, PhD,&nbsp;discusses the treatment options available for younger, fit patients with MCL, including the watch-and-wait approach and BTK inhibitors. He also highlights several clinical trials supporting these strategies, as well as other ongoing trials aiming to advance the treatment landscape for the older patient population.

Newly diagnosed patients with multiple myeloma who are not candidates for high-dose chemotherapy and autologous stem cell transplant saw a 45% reduction in the&nbsp;risk of disease progression or death with the addition of daratumumab (Darzalex) to lenalidomide (Revlimid) and dexamethasone compared with&nbsp;lenalidomide/dexamethasone alone.

Sherene Loi, MBBS, FRACP, PhD, FAHMS, discusses the current status of immunotherapy research in HER2-positive breast cancer.

Both&nbsp;progression-free survival and overall response were improved in patients with&nbsp;<em>MET</em> mutated <em>EGFR</em>-positive non&ndash;small cell lung cancer resistant to prior EGFR TKI therapy who were treated with&nbsp;tepotinib plus gefitinib compared with chemotherapy. These phase II findings were presented at the&nbsp;2018 ESMO Congress.

Based on findings from the phase III KEYNOTE-407 trial, pembrolizumab (Keytruda) has been approved by the FDA for use in combination with carboplatin and either paclitaxel or nab-paclitaxel (Abraxane) for the frontline treatment of patients with metastatic squamous non&ndash;small cell lung cancer.