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Frontline Brentuximab Vedotin Receives FDA's Priority Review for Hodgkin Lymphoma
January 3rd 2018Based on findings from the phase III ECHELON-1 trial, a supplemental biologics application (sBLA) for brentuximab vedotin (Adcetris) in combination with Adriamycin, vinblastine, and dacarbazine (AVD) has been granted a priority review by the FDA for the frontline treatment of advanced classical Hodgkin lymphoma, according to a statement from the company developing the CD30-targeted antibody-drug conjugate, Seattle Genetics.
Novel Iobenguane I-131 Agent Granted FDA's Priority Review for Rare Neuroendocrine Tumors
January 2nd 2018A new drug application for the novel version of the radiopharmaceutical iobenguane I-131 (Azedra) has been granted a priority review by the FDA for the treatment of patients with malignant or recurrent pheochromocytoma or paraganglioma, according to a statement from Progenics Pharmaceuticals, the company developing the novel iodine-131 metaiodobenzylguanidine.
Morse Gives His Perspective on Lines of Therapy for a Patient With Metastatic Colorectal Cancer
December 28th 2017Michael A. Morse, MD, explained his treatment decisions in 1 patient with metastatic colorectal cancer who progresses and requires second-line treatment during a recent <em>Targeted Oncology</em> live case-based peer perspectives dinner.
Ivosidenib Submitted for FDA Approval in IDH1+ AML
December 27th 2017Based on results of a phase I trial presented at the 2017 ASH Annual Meeting, a new drug applicaton for ivosidenib has been submitted for FDA approval for the treatment of patients with relapsed/refractory IDH1-mutant acute myeloid leukemia, according to a statement from Agios Pharmaceuticals, the company developing the targeted therapy.
Nilotinib Label for CML Updated by FDA With Discontinuation Provision
December 26th 2017The label for nilotinib (Tasigna) has been updated by the FDA with a provision stating patients with Philadelphia chromosome-positive chronic myeloid leukemia in the chronic phase (Ph+ CML-CP) who have received the BCR-ABL tyrosine kinase inhibitor could be eligible to stop treatment after having recieved for at least 3 years and having achieved the specific predetermined criteria.<br /> <br />
Stereotactic Radiotherapy Device Given Green Light for Early Breast Cancer by FDA
December 26th 2017Based on findings from a 17-patient study, a novel breast-specific stereotactic body radiotherapy (SBRT) device known as GammaPod has been approved by the FDA as a treatment for patients with early breast cancer.<br /> <br />
Clinical Trials Key to Expanding Novel Treatment Options in Metastatic CRC
December 22nd 2017Shubham Pant, MD, discusses therapeutic options for patients with metastatic CRC, while stressing the importance of clinical trials as an avenue to establish more novel treatment decisions in this setting.
Adjuvant Dabrafenib/Trametinib Granted Priority Review by FDA for BRAF+ Melanoma
December 22nd 2017Based on findings of the phase III COMBI-AD study, a supplemental new drug application for dabrafenib (Tafinlar) combined with trametinib (Mekinist) has been granted a priority review by the FDA as an adjuvant treatment for patients with <em>BRAF</em> V600E– or V600K–positive stage III melanoma following complete resection.
Novel Kinase Inhibitor Shows Encouraging Disease Control in Heavily Pretreated GIST
December 22nd 2017A novel kinase switch control inhibitor, DCC-2618, demonstrated an encouraging disease control rate (DCR) of 76% at 12 weeks in heavily pretreated patients with gastrointestinal stromal tumors (GIST) treated with a daily ≥100-mg dose, according to findings of a phase I first-in-human, dose-escalation trial.
Frontline Avelumab/Axitinib Combo Receives FDA's Breakthrough Designation for RCC
December 22nd 2017The PD-L1 inhibitor avelumab (Bavencio) has been granted a breakthrough therapy designation by the FDA for use in combination with the VEGF inhibitor axitinib (Inlyta) in treatment-naïve patients with advanced renal cell carcinoma.
Expert Weighs in On Recent Adjuvant Therapy Data in Melanoma
December 21st 2017For patients with high-risk melanoma, the area of adjuvant treatment has seen little progress until recently. In large part, this is due to the lack of consensus in the community on what treatments to use, when to use them, and in which patients to implement them, explains Michael B. Atkins, MD.
Apalutamide Granted FDA's Priority Review for Nonmetastatic CRPC
December 21st 2017Based on data from the phase III SPARTAN trial, apalutamide has been granted a priority review by the FDA for the treatment of patients with nonmetastatic castration-resistant prostate cancer, according to Janssen Biotech, the manufacturer of the next-generation oral androgen receptor inhibitor.
Adjuvant Pertuzumab Regimen Receives FDA Approval for HER2+ Breast Cancer
December 21st 2017Based on findings from the APHINITY trial, pertuzumab (Perjeta) has been approved by the FDA in combination with trastuzumab (Herceptin) and chemotherapy for the adjuvant treatment of patients with HER2-positive early breast cancer at high risk for recurrence.
Expert Discusses Promising Results for Denosumab in Patients With Bone Tumors
December 20th 2017In a recent open-label phase II study, denosumab (Xgeva) demonstrated favorable results in patients with resectable giant cell tumor of bone (GCTB). More than one-third of the trial patients avoided surgery and nearly half had less morbidity with surgery when treated with denosumab.
Study Evaluating Several Drugs in Parallel for Newly Diagnosed Glioblastoma
December 20th 2017Several agents are being investigated for the treatment of patients with glioblastoma in an ongoing phase II clinical trial. Known as the INdividualized Screening Trial of Innovative Glioblastoma Therapy, the study will randomize patients to 1 of 4 arms—either the control arm of standard-of-care agent temozolomide, or 1 of 3 experimental arms.
Larotrectinib Demonstrates 93% Response Rate in Pediatric Patients With Solid Tumors
December 20th 2017According to findings from the phase I SCOUT trial, the novel pan-TRK inhibitor larotrectinib (LOXO-101) achieved a 93% response rate in pediatric patients with <em>TRK</em> fusion–positive solid tumors.
Ibrutinib Plus Chemoimmunotherapy Demonstrates Promising Frontline Results in CLL
December 19th 2017In patients with chronic lymphocytic leukemia (CLL), the addition of ibrutinib to standard frontline chemoimmunotherapy induced negative minimum residual disease (MRD) status in bone marrow for 83% of patients, according to results from a preliminary clinical study presented at the 2017 ASH Annual Meeting.
Selinexor Combo Induces 84% ORR in Relapsed/Refractory Myeloma
December 19th 2017Rapid and durable responses were induced with the combination of selinexor, weekly bortezomib (Velcade), and low-dose dexamethasone (Vd), according to results of a dose escalation/expansion trial of patients with relapsed/refractory multiple myeloma (RRMM) presented at the 2017 ASH Annual Meeting.
Frontline Osimertinib Granted FDA's Priority Review for NSCLC
December 19th 2017A supplemental new drug application (sNDA) for osimertinib (Tagrisso) has been granted a priority review by the FDA as a first-line treatment for patients with non–small cell lung cancer (NSCLC) whose tumors harbor <em>EGFR</em> mutations (exon 19 deletions or exon 21 [L858R] substitution mutations).
Olaparib/Durvalumab Combo Demonstrates 80% DCR in HR+/HER2- Breast Cancer
December 16th 2017According to phase II findings from the MEDIOLA trial presented at the 2017 San Antonio Breast Cancer Symposium, the combination of olaparib and durvalumab demonstrated a disease control rate of 80% for pretreated patients with germline <em>BRCA-</em>mutated, HER2-negative metastatic breast cancer, according to phase II findings from the MEDIOLA trial.