News

The FDA’s Oncologic Drugs Advisory Committee will no longer review the supplemental Biologics License Application for luspatercept-aamt for use as treatment of anemia in adult patients with very low- to intermediate-risk myelodysplastic syndromes at the meeting on December 18, 2019.

The triplet regimen of the CXCR4 inhibitor BL-8040, pembrolizumab, plus chemotherapy demonstrated high response and disease control rates in patients with metastatic pancreatic adenocarcinoma, according to preliminary findings from the COMBAT/KEYNOTE-202 trial that were announced in a press release from BioLineRx Ltd, the developer of BL-8040.

In an interview with Targeted Oncology, Mark W. Bustoros, MD, discussed the findings from the study evaluating the genomic predictors of progression in patients with SMM and how these findings will impact treatment decisions for these patients in the future.

As cancer therapies have evolved and individualized treatments have de-veloped over time, patient-centered care has become more prevalent, and oncology teams must consider it to maximize the chances of positive patient outcomes.

Hodgkin lymphoma represents approximately 10% of all cases of malignant lymphoma. This group of diseases most commonly affects adolescent and young adults, although approximately 20% to 25% of patients are aged ≥60 years at diagnosis.

The FDA Oncologic Drugs Advisory Committee has announced a hearing to discuss a supplemental new drug application for olaparib tablets&nbsp;<a>for the maintenance treatment of adult patients with deleterious or suspected deleterious germline&nbsp;<em>BRCA-</em>mutant metastatic pancreatic adenocarcinoma</a>&nbsp;who have not progressed on first-line platinum-based chemotherapy.

Lenvatinib is now indicated for the treatment of differentiated thyroid cancer in China as a result of application acceptance by the National Medical Products Administration of China, according to a press release from Eisai Co., Ltd.<br /> &nbsp;

When treatment decisions are being made regarding chronic lymphocytic leukemia (CLL), patient age should be an important factor. CLL is a disease of the elderly, with more than 40% of all patients &gt;75 years.

The FDA granted an Investigational Device Exemption approval to the Personal Genome Diagnostics Inc. elio^TM&nbsp;tissue complete assay for use in a Merck trial evaluating pembrolizumab combinations in non&ndash;small cell lung cancer, according to a press release from PGDx, developer of the assay.

Onvansertib inhibits tumor growth in patients with acute myeloid leukemia who are resistant to venetoclax, according to the in-vitro and in-vivo data from a phase II trial announced in a press release issued by Trovagene, Inc.

An Investigational New Drug application for chimeric antigen receptor-T cell agent, ICTCAR014, has been cleared by the FDA for treatment of patients with relapsed/refractory non-Hodgkin lymphoma, including those with PD-L1-positive tumors, according to a press release from Innovative Cellular Therapeutics.

New results from the FLAURA trial have shown that patients with treatment-na&iuml;ve, EGFR&nbsp;mutation&ndash;positive advanced non&ndash;small-cell lung cancer who received first-line osimertinib experienced improved overall survival compared with patients who received either gefitinib or erlotinib.

Abatacept has been granted a Breakthrough Therapy Designation by the FDA for the prevention of moderate to severe acute graft-versus-host disease in hematopoietic stem cell transplants from unrelated donors.

The FDA has granted a Regenerative Medicine Advanced Therapy designation to ADP-A2M4 for the treatment of patients with synovial sarcoma, according to a press release from Adaptimmune Therapeutics, developers of the agent.

The FDA has approved the combination of atezolizumab in combination with carboplatin plus nab-paclitaxel chemotherapy for the treatment of patients with metastatic nonsquamous non&ndash;small cell lung cancer, according to a press release from Genentech USA, Inc.<br /> &nbsp;

A significant proportion of patients with metastatic castration-resistant prostate cancer with DNA repair gene aberrations responded well to treatment with olaparib in a phase II TOPARP-B trial, making olaparib the first targeted therapy to show benefit in this patient population, the Institute of Cancer Research reported in a press release.

A phase II study of experimental anti-mitochondrial drug devimstat in patients with relapsed/refractory Burkitt&rsquo;s lymphoma/leukemia has been expanded to include patients at Massachusetts General Hospital in Boston, Massachusetts, according to a press release from Rafael Pharmaceuticals, Inc.

In an interview with&nbsp;Targeted Oncology, Fr&eacute;d&eacute;ric Lehmann, MD, discussed the results for the alloSHRINK trial that were presented at the SITC 34^thAnnual Meeting. The allogenic CAR T-cell therapy, CYAD-101, in association with FOLFOX chemotherapy showed promising antitumor activity in patients with refractory mCRC.

In an interview with Targeted Oncology, Massimo Cristofanilli, MD, discussed emerging treatment approaches for patients with ER-positive/HER2-negative breast cancer with an ESR1 mutation.

In November 2019, the FDA approved a number of treatments, including acalabrutinib for the treatment of chronic lymphocytic leukemia and small lymphocytic leukemia, as well as zanubrutinib for the treatment of mantle cell lymphoma. A biosimilar for pegfilgrastim was also approved under indications.

The FDA has granted priority review to a new supplemental Biologics License Application for pembrolizumab, for which Merck is seeking approval for the treatment of patients with Bacillus Calmette-Guerin-unresponsive, high-risk, non-muscle invasive bladder cancer with carcinoma-in-situ with or without papillary tumors who are either ineligible for cystectomy or have chosen not to undergo the procedure, according to a press release from Merck.

A supplemental Biologics License Application for durvalumab has been accepted by the FDA, and the drug has been granted priority review for the treatment of previously untreated extensive-stage small cell lung cancer, according to a press release from AstraZeneca.

A plethora of new technology has been developed to assist in identifying targetable mutations, including next- generation sequencing. NGS assays that identify tumor genes can range in use from targeted to comprehensive panels, all of which have accelerated the advancement of personalized medicine.

Approximately 20% of cancers worldwide are linked to an infectious agent. Currently, there are seven known oncogenic viruses, which include Epstein-Barr virus, hepatitis virus B and C, human papillomavirus, human T cell lymphoma virus 1, Kaposi sarcoma virus and Merkel cell polyomavirus. Among these agents, HBV, HCV and HPV each contribute to ap- proximately 5% of all cancer cases.

In a Targeted Oncology live case-based peer perspectives discussion, Mark Agulnik, MD, and Simon S. Yoo, MD, discussed with a group of physicians the staging criteria and the options for treatment for patients with cutaneous squamous cell carcinoma.

Precision and personalized medicine targeting driver mutations has revolutionized cancer care in the past decade. Targeted therapy has entered the world of colorectal cancer research with the identification of mutations in KRAS and BRAF genes.

GDC-0084, an investigational PI3K inhibitor, may delay the progression of disease in patients with newly diagnosed glioblastoma and unmethylated MGMT promotor status, based on results of a phase IIa study, Kazia Therapeutics reported in a press release.

In an interview with&nbsp;Targeted Oncology, Pavlos Msaouel, MD, PhD, discussed the findings from the trial evaluating sitravatinib plus nivolumab in patients with advanced/metastatic urothelial carcinoma. He also highlighted the next steps for this combination regimen.

The FDA has granted a priority review designation to a New Drug Application for pemigatinib, as a treatment for patients with previously treated, locally advanced or metastatic cholangiocarcinoma with FGFR2 fusions or rearrangements, according to a press release from Incyte.

Triple-negative breast cancer &mdash; defined as tumors that lack expression of estrogen receptor, progesterone receptor, and human epidermal growth factor receptor 2 amplification&mdash; is a heterogenous disease and clinically represents a major unmet need in the field of oncology. TNBC is associated with aggressive tumor biology and higher risk of recurrence and visceral metastasis, including brain metastasis.