Ease of Use With Subcutaneous Daratumumab Supplants the Intravenous Formulation as Standard of Care Across Settings in MyelomaJune 25th 2020
In an interview with Targeted Therapies in Oncology, C. Ola Landgren, MD, PhD, discussed how the availability of daratumumab by subcutaneous administration will affect clinical practice going forward.
Gerber Addresses the Role of Mutations and Treatment in NSCLC at Different StagesMay 23rd 2020
In a Targeted Oncology case-based peer perspectives live discussion, David Gerber, MD, addresses the role of biomarkers in guiding treatment decisions for patients with non–small cell lung cancer based on a patient scenario.
FDA Approves Subcutaneous Daratumumab With Hyaluronidase in Multiple Myeloma IndicationsMay 1st 2020
The FDA has approved the use of daratumumab in combination with hyaluronidase-fihj (Darzalex Faspro) for the treatment of adult patients with newly diagnosed or relapsed/refractory multiple myeloma. The newly approved product allowed for subcutaneous dosing of daratumumab.
Aggarwal Reviews the Latest Data Related to Systemic Therapy in Stage III NSCLCApril 19th 2020
In a Targeted Oncology case-based peer perspectives live discussion, Charu Aggarwal, MD, MPH, discussed systemic treatment options for stage III non–small cell lung cancer, based on a real case of a 63-year-old male patient.
Alpelisib Receives FDA Approval in Breast CancerMay 24th 2019
Based on data from the phase III SOLAR-1 trial, alpelisib (Piqray) has been approved by the FDA for the treatment of postmenopausal women, and men, with HR-positive, HER2-negative, PIK3CA-mutated, advanced or metastatic breast cancer following progression on or after an endocrine-based regimen.
Venetoclax/Obinutuzumab Combo Approved by FDA for Frontline CLLMay 15th 2019
The combination of venetoclax (Venclexta) and obinutuzumab (Gazyva) has been approved by the FDA for the frontline treatment of patients with chronic lymphocytic leukemia or small lymphocytic lymphoma, based on findings from the phase III CLL14 trial.
Erdafitinib Granted FDA Approval in Bladder CancerApril 12th 2019
Erdafitinib (Balversa) has been granted an accelerated approval by the FDA as a treatment for adult patients with locally advanced or metastatic bladder cancer with an <em>FGFR3</em> or <em>FGFR2</em> alteration that has progressed on platinum-containing chemotherapy, making it the first targeted agent to receive approval for metastatic bladder cancer.
Palbociclib Approved by FDA for Treatment of Male Patients With HR+/HER2- Breast CancerApril 5th 2019
The indication for palbociclib capsules in combination with endocrine therapy now includes the treatment of male patients with hormone receptor–positive, HER2-negative advanced or metastatic breast cancer after being expanded by the FDA.
NCCN Updates Guidelines for BRAF-Mutant CRC to Include Triplet With Encorafenib And BinimetinibMarch 19th 2019
The clinical practice guidelines for the treatment of patients with colorectal cancer have been updated by NCCN to include the combination of encorafenib plus binimetinib in addition to EGFR inhibition with either cetuximab or panitumumab as a Category 2a treatment recommendation for patients with <em>BRAF</em> V600E–mutant metastatic CRC, after 1 or 2 prior therapies for metastatic disease.
Darolutamide Submitted for FDA Approval in Nonmetastatic CRPCFebruary 27th 2019
Based on findings from the phase III ARAMIS trial, a new drug application for darolutamide has been submitted to the FDA seeking the investigational agent's approval as a treatment for patients with nonmetastatic castration-resistant prostate cancer, according to the codevelopers of the investigational agent, Bayer and Orion Corporation.<br />
Frontline Olaparib Succeeds as Maintenance Therapy in BRCA+ Pancreatic CancerFebruary 27th 2019
AstraZeneca and Merck, the codevelopers of olaparib, have announced that findings from the phase III POLO trial showed use of the PARP inhibitor as a frontline maintenance for patients with germline <em>BRCA</em>-mutated metastatic adenocarcinoma of the pancreas significantly reduced the risk of disease progression or death versus placebo.
Phase III Trial Confirms Subcutaneous Daratumumab Noninferior to Standard in MyelomaFebruary 26th 2019
According to findings from the phase III COLUMBA trial in patients with relapsed/refractory multiple myeloma, a subcutaneous formulation of daratumumab is noninferior in terms of inefficacy and pharmacokinetics to the standard intravenous daratumumab.
Phase III Ovarian Cancer Study Terminated After Frontline Avelumab Falls ShortJanuary 3rd 2019
At a planned interim analysis of the phase III JAVELIN Ovarian 100 study evaluating frontline avelumab in ovarian cancer, an independent panel determined the study would not meet its primary endpoint of progression-free survival. The co-developers of the PD-L1 inhibitor have announced they will terminate the trial on this basis.
Romiplostim Receives FDA Approval for Pediatric ITPDecember 15th 2018
Romiplostim has been granted FDA approval for the treatment of pediatric patients aged ≥1 year with immune thrombocytopenia for at least 6 months who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy.
Frontline Venetoclax Granted Accelerated FDA Approval for Older Patients With AMLNovember 21st 2018
Venetoclax (Venclexta) has been granted an accelerated approval by the FDA for combined use with azacitidine or decitabine or low-dose cytarabine as a treatment for adult patients with newly-diagnosed acute myeloid leukemia who are aged 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy.
PFS Improved With Tivozanib in Highly Refractory RCCNovember 8th 2018
According to topline findings from the phase III TIVO-3 trial, tivozanib (Fotivda) reduced the risk of disease progression or death by 26% compared with sorafenib (Nexavar) in patients with highly refractory advanced or metastatic renal cell carcinoma.
PFS Improvement With Venetoclax Plus Obinutuzumab in Frontline CLLNovember 1st 2018
Treatment-naïve patients with chronic lymphocytic leukemia who had comorbidities saw a reduction in the risk of disease progression or death after treatment with venetoclax combined with obinutuzumab versus obinutuzumab plus chlorambucil.
TAS-102 Granted Priority Review by FDA for Gastric/GEJ CancerOctober 26th 2018
Based on data from the phase III TAGS trial, a supplemental new drug application seeking approval for TAS-102 (trifluridine/tipiracil; Lonsurf) for use in previously treated patients with advanced or metastatic gastric adenocarcinoma, including cancer of the gastroesophageal junction, has been granted a priority review by the FDA.
Frontline Pembrolizumab/Axitinib Combo Demonstrates Survival Benefit in RCCOctober 19th 2018
Patients with advanced or metastatic renal cell carcinoma who were treated with the combination of pembrolizumab (Keytruda) and axitinib (Inlyta) demonstrated a significantly improved survival benefit compared with sunitinib (Sutent) in the first-line setting, meeting the endpoints of the pivotal phase III KEYNOTE-426 trial.