Nichole Tucker

The FDA released a draft guidance document entitled “Demonstrating Substantial Evidence of Effectiveness for Human Drug and Biological Products Guidance for Industry” to clarify the evidence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 The draft guidance is designed to aid the submission of  new drug applications, biologics license applications, or applications for supplemental indications.

Individuals with obesity who were diagnosed with locally advanced or metastatic clear cell renal cell carcinoma achieved longer overall survival than patients of normal weight in select groups of an independent cohort study, which evaluated overall survival and the transcriptomic differences in the primary tumor and peritumoral adipose tissue in adult patients with metastatic clear cell renal cell carcinoma.

With the absence of a standard of care for chronic neutrophilic leukemia and atypical chronic myeloid leukemia, 2 rare BCR-ABL1-negative myeloid neoplasms, ruxolitinib may be a viable treatment option after a phase II study showed potential for response in this patient population.

In an interview with Targeted Oncology at the 2019 Ruesch Center Symposium, Benjamin Weingberg, MD, shared key points from his discussion on mining the microbiome in patients with colorectal cancer and summarized the treatment landscape for patients with metastatic disease. He also discussed an upcoming basket trial that uses liquid biopsies to place patients on treatment plans that will be most effective for their individual needs.

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.

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;

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;

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;

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;

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;

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;

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;

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.

Preliminary data showed that the combination of sitravatinib and tislelizumab is well tolerated and may promote antitumor activity when administered to patients with platinum-resistant ovarian cancer, according to a press release from BieGene, Ltd, which reported data from a phase Ib study at the 2019 European Society of Oncology Immuno-Oncology Congress in Geneva, Switzerland.<br /> &nbsp;

With the inevitability of resistance to first- and second-generation EGFR tyrosine kinase inhibitors in patients with EGFR-mutant non&ndash;small cell lung cancer, novel options like lazertinib, an irreversible, third-generation, mutant-selective, EGFR TKI are being explored. Lazertinib has shown promise for the treatment of this patient population, according to a phase I/II dose-escalation study published in The Lancet Oncology.

The combination of atezolizumab, cobimetinib, and vemurafenib reduced the risk of disease progression or death compared with placebo in patients with&nbsp;BRAF&nbsp;V600 mutation-positive advanced melanoma, meeting the primary endpoint of progression-free survival in the phase III IMspire150 study, according to a press release from Roche.

A Biologics License Application for the investigational chimeric antigen receptor T-cell therapy agent, KTE-X19 has been submitted to the FDA for the treatment of adult patients with relapsed/refractory mantle cell lymphoma, according to a press release from Kite.<br /> &nbsp;

A retrospective study has shown that only 40% of patients with metastatic colorectal cancer received biomarker testing prior to treatment, as recommended in the National Comprehensive Cancer Network guidelines. As a result, patients receive less effective therapies and experience serious adverse events, according to a press release from Guardant Health.

Zotiraciclib has been granted Orphan Drug Designation by the FDA for the treatment of patients with glioblastoma, according to a press release from Adastra Pharmaceuticals, Inc.

The new phase III MOMENTUM clinical trial, which is evaluating the efficacy of momelotinib, a JAK1, JAK2 and ACVR1 inhibitor, versus active comparator danazol in patients with symptomatic and anemic myelofibrosis, was recently launched globally, according to a press release from Sierra Oncology.

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;

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.

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 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.