News

The FDA has granted a Fast Track Designation to the immune-gene therapy Oncoprex in combination with the EGFR inhibitor osimertinib for the treatment of patients with&nbsp;<em>EGFR</em>-mutant non&ndash;small cell lung cancer who have progressed after treatment with osimertinib alone.

The FDA granted Priority Review to the Biologics License Application for belantamab mafodotin, an anti&ndash;B cell maturation antigen monoclonal antibody for the treatment of patients with relapsed or refractory multiple myeloma whose prior therapies included an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody, GlaxoSmithKline plc announced in a press release.<br /> &nbsp;

Durvalumab and tremelimumab have been granted Orphan Drug Designation for the treatment of hepatocellular carcinoma, according to a press release from AstraZeneca.

A new phase III trial has found that luspatercept reduced the severity of anemia in patients with transfusion-refractory, lower-risk myelodysplastic syndromes with ring sideroblasts. Results from the MEDALIST trial, which included data from 65 sites in 11 countries, were published recently in the New England Journal of Medicine.

The FDA has granted a Priority Review to the New Drug Application for olaparib as treatment for patients with metastatic castration-resistant prostate cancer and deleterious or suspected deleterious germline or somatic homologous recombination repair gene mutations, who have progressed following prior treatment with a new hormonal agent, AstraZeneca reported in a press release.

In an interview with&nbsp;Targeted Oncology, Pier Francesco Ferrucci, MD, discussed the findings from the updated analysis, which he shared in a presentation at the 16th International Congress of the Society for Melanoma Research, highlightening the important takeaways from this follow-up analysis.

The Investigational New Drug Application for the novel EGFR tyrosine kinase inhibitor BBT-176 was cleared by the FDA for treatment of&nbsp;EGFR C797S&ndash;mutant non&ndash;small cell lung cancer, according to a press release from Bridge Biotherapeutics, Inc, developer of BBT-176.

Lenvatinib demonstrated a longer median overall survival compared with palliative therapy in patients with stage IVC anaplastic thyroid cancer, a rare disease for which the survival rate has not improved in roughly 20 years. The introduction of targeted therapy to the treatment landscape for anaplastic thyroid cancer has been challenging in the past because some patients do not have time to undergo therapy on a clinical trial because the process is time-consuming, and the procedure for study enrollment may exceed time to progression.

Ruxolitinib plus low-dose&nbsp;pegylated interferon-a2 improved peripheral blood cell counts, bone marrow cellularity and fibrosis, and symptom burden with acceptable toxicity in patients with polycythemia vera or proliferative myelofibrosis, according to the 2-year, end-of-study results of the phase II COMBI study, which were recently published in Haematologica.

In an interview with&nbsp;Targeted Oncology, Ruben Mesa, MD, discussed the findings from the pooled analysis of fedratinib at full dose in patients with myelofibrosis who had baseline platelet counts below 100 X 10⁹/L. He also highlighted other agents and therapies that appear promising for the treatment of patients with myeloproliferative neoplasms.

For patients with non&ndash;small cell lung cancer, having a body mass index &ge;30 at baseline could be independently associated with an improvement in overall survival with atezolizumab and could be considered a stratification factor in immune checkpoint inhibitor trials, according to a study published in JAMA Oncology.

In an interview with&nbsp;Targeted Oncology, Steven H. Kirtland, MD, FCCP, discussed the different factors that play a role in the decline of lung cancer mortality over the last few years. He highlighted how these advancements will continue to impact the survival of patients with lung cancer and his thoughts on the evolving landscape.

In an interview with&nbsp;Targeted Oncology,&nbsp;Pasi A. J&auml;nne, MD, PhD,&nbsp;discussed the current treatment landscape for patients with&nbsp;EGFR-mutant lung cancer, as well as some therapies that currently are under both preclinical and clinical investigation at the Dana-Farber Cancer Institute. He shared advice for community oncologists treating this patient population.

In an interview with&nbsp;Targeted Oncology, John M. Burke, MD, discussed the ongoing phase Ib First-MIND clinical trial of tafasitamab in combination with R-CHOP with or without lenalidomide as treatment of patients with newly diagnosed diffuse large B-cell lymphoma.

In an interview with&nbsp;Targeted Oncology, Eric Pujade-Lauraine, MD, PhD, discussed the data from the JAVELIN Ovarian 200 trial, which he presented at the 2019 Society of Gynecologic Oncology Annual Meeting. He highlighted the need for biomarkers in this space, as well as some data from an exploratory analysis from this trial.

A rolling submission of a New Drug Application for umbralisib has been initiated by drug developer, TG Therapeutics, Inc, which is requesting accelerated approval of the agent from the FDA for the treatment of patients with previously treated marginal zone lymphoma and follicular lymphoma. The company reported in a press release that one application was considered to be acceptable for both drugs and the NDA will be completed in the first half of 2020.<br /> &nbsp;

The autologous dendric cell vaccine targeting Wilms tumor-1 antigens with or without preferentially Expressed Antigen in Melanoma was well tolerated and feasible in patients with acute myeloid leukemia, meeting the co-primary end points of the phase I/II clinical trial.

The FDA has granted priority review to the Biologics License Application for nivolumab in combination with ipilimumab for the first-line treatment of patients with metastatic or recurrent non-small cell lung cancer with no EGFR or ALK genomic tumor aberrations, according to a press release from the Bristol-Myers Squibb Company.<br /> &nbsp;

The FDA has granted priority review status on a supplemental New Drug Application for rucaparib in advanced prostate cancer, according to a release issued by Clovis Oncology.1 The sNDA seeks approval for rucaparib as monotherapy treatment in patients with a BRCA1/2 mutation resulting in recurrent metastatic castrate-resistant prostate cancer. The agency has assigned a Prescription Drug User Fee Act date of May 15, 2020.

Salvage therapy with high&#8208;dose cyclophosphamide showed meaningful clinical activity in a cohort of 6 patients with mantle cell lymphoma who were previously treated with &ge;2 prior lines of therapy and had no other available options. These patients made up 14% of the 42 participants in a phase II study showing similar efficacy in adult patients with other relapsed or refractory B&#8208;cell non&#8208;Hodgkin lymphomas.

To support the commercialization of the blood-based companion diagnostic test Guardant360 companion diagnostic for AMG 510, Guardant Health, Inc, will collaborate with Amgen, developer of AMG 510, and pursue an FDA Pre-Market Approval as a companion diagnostic for AMG 510 in patients with metastatic non&ndash;small cell lung cancer with a&nbsp;KRAS&nbsp;G12C mutation, according to a press release.

In an interview with&nbsp;Targeted Oncology, Rajat Bannerji, MD, PhD, discussed the safety and efficacy findings from the phase I trial of a bispecific antibody in patients with heavily pretreated NHL, including cohorts of patients with follicular lymphoma and diffuse large B-cell lymphoma.

In an interview with&nbsp;Targeted Oncology, Andrew J. Cowan, MD, discussed the findings from the first-in-human clinical trial evaluating the combination of a GSI and BCMA CAR T cells in patients with heavily pretreated multiple myeloma. He highlighted the next steps for this research and how he sees CAR T-cell therapy evolving over the coming years.

The supplemental New Drug Application for olaparib, a PARP inhibitor, in combination with bevacizumab has been granted Priority Review by the FDA as maintenance treatment of patients with advanced ovarian cancer who are in complete or partial response to first-line platinum-based chemotherapy, based on the results from the phase III PAOLA-1 trial, according to a press release from AstraZeneca and Merck &amp; Co, Inc.1<br /> &nbsp;

The real-world efficacy and safety demonstrated with tisagenlecleucel, a chimeric antigen receptor T-cell therapy for the treatment of patients with diffuse large B-cell lymphoma, was similar to results from the pivotal JULIET trial, according to Samantha Jaglowski, MD professor at the Ohio State University Comprehensive Cancer Center patients.

Results from a phase II, open-label, multicenter study have shown that patients with heavily pretreated multiple myeloma responded to ibrutinib combined with bortezomib (Velcade) and dexamethasone.

The CD19-directed CAR T-cell therapy lisocabtagene maraleucel demonstrated promising responses and a manageable toxicity profile in patients with high-risk chronic lymphocytic leukemia or small lymphocytic leukemia who have previously progressed on ibrutinib in the updated findings from the phase I/II TRANSCEND CLL 004 study.

Pralsetinib&nbsp; a highly-selected RET inhibitor, achieved a favorable overall response rate with prolonged durability in patients with RET fusion&ndash;positive non&ndash;small cell lung cancer who were previously treated with platinum-based chemotherapy, according to top-line results from the phase I/II ARROW trial, announced the Blueprint Medicines Corporation in a press release.

In an interview with Targeted Oncology, Simon Rule, MD,&nbsp;discussed the findings from&nbsp;a pooled analysis evaluating the efficacy and safety of using ibrutinib in patients with relapsed/refractory mantle cell lymphoma.&nbsp;He also highlighted other abstracts of interest that were presented during the 2019 American Society of Hematology Annual Meeting that were of interest in the field of mantle cell lymphoma.

The FDA has approved avapritinib for the treatment of adults with unresectable or metastatic gastrointestinal stromal tumor who harbor platelet-derived growth factor receptor alpha exon 18 mutation, including PDGFRA D842V mutations. This approval makes avapritinib the first precision medicine therapy for a genomically defined population of patients with GIST, according to a press release from the Blueprint Medicines Corporation.