News

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.

An update to the phase II study of loncastuximab tesirine in patients with relapsed or refractory diffuse large B-cell lymphoma showed promising overall response rate, according to a press release from ADC Therapeutics SA.

The phase II TELLOMAK trial, which is evaluating the safety and efficacy of lacutamab in patients with advanced T-cell lymphomas, has been placed on a partial clinical hold by the FDA. The decision was made following discussions regarding Good Manufacturing Practice deficiencies at a subcontractor site that manufacturers the agent&nbsp;in December of 2019, according to a press release from Innate Pharma SA.

In an interview with&nbsp;Targeted Oncology, Wasif M. Saif, MD, discussed the current treatment landscape and recent expansions in hepatocellular carcinoma that are providing him with hope for the field.

The combination of pembrolizumab and chemotherapy improved progression-free survival in patients with small cell lung cancer compared with chemotherapy alone, meeting 1 of the primary end points of the phase III KEYNOTE-604 study, according to a press release from pembrolizumab developer, Merck. Compared with a chemotherapy regimen of either etoposide plus cisplatin or cisplatin alone, the progression-free survival mprovement with pembrolizumab was significant.

Pembrolizumab is now FDA approved for the treatment of patients with Bacillus Calmette-Guerin&ndash;unresponsive, high-risk, non-muscle invasive bladder cancer with carcinoma in situ with or without papillary tumors who are ineligible for or have elected not to undergo cystectomy.

The overall response rate was improved with itacitinib plus corticosteroids compared with placebo plus corticosteroids in patients with treatment-na&iuml;ve acute graft-versus-host disease in the phase III GRAVITAS-301 trial. However, the difference in ORR for the treatment arm compared with the placebo arm was not statistically significant, missing the trial&rsquo;s primary end point.

In an interview with&nbsp;<em>Targeted Oncology</em>, Constantine S. Tam, MD, discussed the findings of&nbsp;the phase III CAPTIVATE study.&nbsp;

The Ion Torrent Oncomine Myeloid Research Assay, the first fully-integrated next-generation sequencing platform, will be available in 2020 on the new Ion Torrent Genexus System for research use, according to a press release from Thermo Fisher Scientific. The platform features automated workflow to allow for result delivery within a single day, requiring minimal user intervention and tissue sample input.

In an interview with&nbsp;Targeted Oncology, Courtney D. DiNardo, MD, discussed the interim analysis results from the ongoing phase II trial evaluating the combination of enasidenib plus azacitidine in newly diagnosed patients with acute myeloid leukemia.

A phase Ib/2 clinical trial has been initiated to assess the anti-tumor activity of FGFR4 targeted therapy fisogatinib plus the anti&ndash;PD-L1 monoclonal antibody CS1001 for the treatment of patients with locally advanced or metastatic hepatocellular carcinoma.

In an interview with Targeted Oncology at the 2019 San Antonio Breast Cancer Conference, Antionette Tan, MD, shared the results of the FeDEriCa study and explained how the results can impact the treatment of patients with HER2-positive breast cancer in the clinical setting.

Overall survival was significantly improved in patients with locally advanced or metastatic urothelial cancer who received first-line maintenance treatment with avelumab versus standard of care, meeting the primary end point of the phase III JAVELIN Bladder 100 study, Pfizer announced in a press release.

Infigratinib has been granted Fast Track Designation by the FDA for the treatment of cholangiocarcinoma in adult patients with first-line advanced or metastatic disease, according to a press release from QED Therapeutics, a subsidiary of BridgeBio Pharma, Inc, and developer of infigratinib.

In an interview with&nbsp;Targeted Oncology&nbsp;at the 2019 Ruesch Symposium, Fearon, professor, Weil Cornell Medicine, discussed his presentation on the CXCL-12 pathway, which can exclude T cells from pancreatic ductal adenocarcinoma. He also shared his opinion on how to advance the treatment landscape in the future.

CLR 131, a small-molecule, targeted Phospholipid Drug Conjugate, has been granted Orphan Drug Designation by the FDA for the treatment of patients with lymphoplasmacytic lymphoma, according to a press release from Cellectar BioSciences, Inc, developer of the drug.<br /> &nbsp;

The FDA granted approval to countless treatments across cancer types throughout 2019 until the end of the year, with a final approval on December 31^st&nbsp;for the first BRCA targeted therapy in pancreatic cancer. Following the excitement for a new year of further advances,&nbsp;Targeted Oncology&nbsp;followers on Twitter shared their thoughts on some of the most impactful FDA approvals in 2019.

The FDA released a draft guidance document entitled &ldquo;Demonstrating Substantial Evidence of Effectiveness for Human Drug and Biological Products Guidance for Industry&rdquo; to clarify the evidence required to prove the effectiveness of drugs and biologics. The statement is a supplement for the 1998 guidance entitled &ldquo;Providing Clinical Evidence of Effectiveness for Human Drug and Biological Products.&rdquo; The draft guidance is designed to aid the submission of&nbsp; new drug applications, biologics license applications, or applications for supplemental indications.