News

Selpercatinib will be compared with the standard of care in the first ever phase III clinical trial in patients with advanced or metastatic treatment-na&iuml;ve&nbsp;<em>RET</em>&nbsp;fusion-positive non&ndash;small cell lung cancer, according to a press release from Eli Lilly and Company.

A trastuzumab biosimilar has officially been prequalified as the first biosimilar by the World Health Organization, which may be used for the treatment of breast cancers, according to a press release. The organization predicts this will be more affordable for patients and will, therefore, expand access to treatment.

Results from a phase I/Ib trial showed revealed that preliminary activity was seen with IMGN632, an investigational anti-CD123 antibody-drug conjugate, given to patients with relapsed/refractory acute myelogenous leukemia or blastic plasmacytoid dendritic cell neoplasm, according to data presented at the 2019 ASH Annual Meeting.

Recent study results suggest that guideline recommendations for biomarker testing in metastatic colon cancer are not consistent with real-world care. A retrospective review of the COTA Real World Data database showed suboptimal adherence to testing guidelines for RAS, BRAF, and microsatellite instability (MSI)/mismatch repair deficiency in this patient population.

Shekeab Jauhari, MD, a medical oncologist/hematologist, has been named principal investigator at the Florida Cancer Specialists &amp; Research Institute, and he will lead phase I clinical trials at the FCS Drug Development Unit in Lake Mary, Florida, at the Sarah Cannon Research Institute, which is the newest unit in the FCS that is set to open in January 2020.

The incidence of thyroid cancer in the United States may be on decline since the rise in thyroid cancer diagnoses observed between 1974 and 2013. This finding is based on observational analysis of data from the Surveillance, Epidemiology, and End Results 13 registry, which were recently published in JAMA.<br /> &nbsp;

In an interview with Targeted Oncology, Ian W. Flinn, MD, PhD, discussed the results from the ZUMA-2 trial which evaluated the efficacy and safety of KTE-X19, a CAR T-cell therapy, in patients with relapsed/refractory mantle cell lymphoma. He highlighted how unique this product is compared to other CAR T-cell therapies and where he believes it will fit into the treatment landscape for patients with mantle cell lymphoma.

Tucatinib developer, Seattle Genetics, Inc., has submitted a new drug application to the FDA for tucatinib in combination with trastuzumab and capecitabine for the treatment of patients with advanced unresectable or metastatic HER2-positive breast cancer, including those with brain metastases, who have received at least 3 prior HER2-directed drugs alone or in combination with other drugs, in the neoadjuvant, adjuvant, or metastatic setting, according to a press release.<br /> &nbsp;

A new drug application for selinexor has been submitted to the FDA for the treatment of patients with relapsed or refractory diffuse large b-cell lymphoma who have had at least 2 prior multi-drug therapies,and who are ineligible for stem cell transplantation, including chimeric antigen receptor T-cell therapy, according to a press release from Karypharm Therapeutics, developer of selinexor.<br /> &nbsp;

The first half-yearly follow-up&nbsp;results from a phase I study of ilixadencel monotherapy in patients with advanced gastrointestinal stromal tumors will be presented by Alex Karlsson-Parra, MD, PhD on February 6, 2020, during poster session A, at the Clinical Immuno-Oncology Symposium, according to a press release from Immunicum AB, where Karlsson-Parra serves as the chief executive officer.<br /> &nbsp;

Older patients with mantle cell lymphoma were more likely to have a maintained response with induction rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone followed by rituximab maintenance when compared against R-CHOP and interferon-alpha maintenance.

Fam-trastuzumab deruxtecan-nxki has been granted an accelerated approval by the FDA for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have received at least 2 prior lines of anti&ndash;HER2-based regimens in the metastatic setting.

A biologics license application has been submitted to the FDA for margetuximab in combination with chemotherapy for the treatment of patients with metastatic HER2-positive breast cancer, according to a press release from MacroGenics, Inc.<br /> &nbsp;

A Biologics License Application has been submitted to the FDA for ABP 798, a biosimilar candidate for rituximab, announced Amgen and Allergan, who are collaborating on 4 biosimilar agents together, in a press release.

The target number of patients with advanced gastrointestinal stromal tumors have been enrolled in the phase III VOYAGER study in China, which is evaluating the safety and efficacy investigational drug avapritinib in the third- or fourth-line settings, according to a press release from CStone Pharmaceuticals.<br /> &nbsp;

The FDA has granted a&nbsp;<a>priority review designation to the new drug application&nbsp;</a>for UGN-101 for the potential treatment of patients with low-grade upper tract urothelial cancer, UroGen Pharma Ltd., announced in a press release.

A new study has found that enzalutamide given with androgen deprivation therapy significantly reduced the risk of metastatic progression or death in men with metastatic hormone-sensitive prostate cancer versus placebo plus ADT, including patients with low-volume disease and/or prior docetaxel therapy.<br /> &nbsp;

A new drug application has been filed for accelerated approval with the FDA for lurbinectedin in patients with small cell lung cancer who have progressed after prior platinum-containing therapy, according to the manufacturer, PharmaMar.1 The filing was based on results from a phase II basket trial, presented at the 2019 ASCO Annual Meeting.

A Biologic License Application has been submitted for isocabtagene maraleucel, a chimeric antigen receptor T-cell agent, as a treatment for adult patients with relapsed or refractory large B-cell lymphoma after a minimum of 2 prior therapies, Bristol-Myers Squibb, the manufacturer, reported in a press release.

Enfortumab vedotin-ejfv has been approved by the FDA for treatment of patients with locally advanced or metastatic urothelial cancers who had prior treatment with a PD-1 or PD-L1 inhibitor and a platinum-containing chemotherapy regimen, according to a press release from the FDA.<br /> &nbsp;

The FDA has accepted a supplemental new drug application for the combination of encorafenib and cetuximab for the treatment of patients with advanced&nbsp;BRAF&nbsp;V600E-mutant metastatic colorectal cancer, following 1 or 2 lines of therapy, Pfizer, Inc. reported in a press release.<br /> &nbsp;

In a unanimous vote, the Oncologic Drugs Advisory Committee of the FDA is in favor of the benefit-risk profile of tazemetostat for the treatment of patients with metastatic or locally advanced epithelioid sarcoma who are not eligible for curative intent surgery, according to a press release from Epizyme, Inc., manufacturer of the drug.

In cohort 1 of the phase III ASPEN trial, zanubrutinib demonstrated a higher very good partial response rate and a more tolerable safety profile compared with ibrutinib in patients with Waldenstr&ouml;m macroglobulinemia. However, the study missed its primary end point of statistically significant superiority in complete response and VGPR rates, according to a press release from BeiGene, Ltd, developer of the BTK inhibitor.

The FDA has granted Breakthrough Therapy Designation to the addition of tucatinib to trastuzumab and capecitabine for the treatment of patients with locally advanced unresectable or metastatic HER2-positive breast cancer, including those with brain metastases who received prior treatment with trastuzumab, pertuzumab, and T-DM1, according to a press release from Seattle Genetics.<br /> &nbsp;

Initial data from the phase II CLOVER-1 trial demonstrated an acceptable safety profile for CLR 131 in patients with relapsed/refractory B-cell malignancies, including multiple myeloma, Cellectar Biosciences, Inc., announced in a press release.

Results of the phase II DREAMM-2 trial recently published in The Lancet Oncology showed that the investigational agent belantamab mafodotin induced response rates above 30% and had a manageable safety profile in patients with heavily pretreated multiple myeloma.

In an interview with Targeted Oncology, Jeff P. Sharman, MD, discussed the updated ELEVATE-TN data and ongoing research that is poised to define the optimal role of acalabrutinib in CLL at the 2019 ASH Annual Meeting.

In a 7-to-5 vote, the FDA&rsquo;s Oncologic Drugs Advisory Committee recommended the PARP inhibitor olaparib as first-line maintenance therapy for patients with germline&nbsp;BRCA-mutated metastatic pancreatic cancer whose disease did not progress after first-line treatment with platinum-based chemotherapy, AstraZeneca and MSD, Inc. reported in a press release.<br /> &nbsp;

In an interview with&nbsp;Targeted Oncology, Pinkal Desai, MD, discussed the latest advancements in the treatment landscape for patients with AML, particularly for the older population. She also highlighted emerging treatment options that undergoing investigation now in clinical trials.

The FDA has granted a Fast Track Designation to tipifarnib, a farnesyl transferase inhibitor, for the treatment of patients with <em>HRAS</em>-mutant head and neck squamous cell carcinomas who have previously progressed on platinum therapy, according to a press release from Kura Oncology.