Expanded approval for single-agent pembrolizumab (Keytruda) has arrived from the FDA to include frontline treatment for advanced melanoma regardless of BRAF status, based on a substantial improvement in progression-free and overall survival compared with ipilimumab (Yervoy) in the phase III KEYNOTE-006 trial
Treatment with standard neoadjuvant chemotherapy plus carboplatin and/or bevacizumab resulting in a pathologic complete response has been associated with improvement in event-free and overall survival in patients with triple-negative breast cancer.
Pembrolizumab, a PD-1 inhibitor, had an overall response rate of 12% in patients with PD-L1-positive, ER+/HER2 advanced breast cancer, according to data from the phase Ib KEYNOTE-028 trial.
Palbociclib (Ibrance) has been given a priority review by the FDA. The treatment will be looked at as a combination with fulvestrant in pretreated patients with HR-positive, HER2-negative metastatic breast cancer, said Pfizer, the manufacturer of the CDK 4/6 inhibitor.
Elotuzumab (Empliciti) has been approved by the FDA for use in combination with lenalidomide (Revlimid) and dexamethasone in patients with multiple myeloma after the failure of at least 1 prior therapy.
Optune in conjunction with chemotherapy and/or bevacizumab boosted survival rates in patients with recurrent glioblastoma multiforme.
An FDA panel voted against approval of the immunotherapy MCNA as a treatment for patients with high-risk non-muscle invasive bladder cancer (NMIBC) following first-line bacillus Calmette-Guerin (BCG) therapy.
A supplemental new drug application has been submitted to the FDA for ibrutinib in conjunction with bendamustine and rituximab. The combination would treat patients with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma.
Neoadjuvant chemotherapy is increasingly used in advanced ovarian cancer, even though it has not been shown to improve survival versus primary cytoreduction.
Achieving optimal results with novel antibodies like elotuzumab (Empliciti) and daratumumab in multiple myeloma treatment will involve combination regimens with established agents, according to Sagar Lonial, MD.
Ipilimumab (Yervoy) in melanoma has been approved to include adjuvant treatment of patients with stage III melanoma who are at high risk of recurrence following complete resection by the FDA.
Approval for first-in-class oncolytic immunotherapy talimogene laherparepvec (T-VEC; Imlygic) has come down from the FDA based on the results from the phase III OPTiM study.
Advanced soft tissue sarcoma patients will now be able to receive trabectedin (Yondelis), which has been approved by the FDA after promising results from a phase III trial.
Three months ahead of schedule, nivolumab (Opdivo) has obtained FDA approval for patients with nonsquamous non-small cell lung cancer who progressed on or following platinum-based chemotherapy.
The immunotherapy, pembrolizumab (Keytruda), has been FDA approved for treatment in patients with pretreated advanced non-small cell lung cancer across all histologies with tumors expressing PD-L1.
The risk of death for patients with advanced renal cell carcinoma (RCC) was reduced by 27% with nivolumab (Opdivo) versus everolimus (Afinitor), and overall survival (OS) was improved by 5.4 months.
The oral nucleoside TAS-102 (Lonsurf) has been approved by the FDA for patients with advanced colorectal cancer (CRC) who are not responding to other treatments.
The PD-1 inhibitor immunotherapy Nivolumab (Opdivo) has received an FDA breakthrough therapy designation for the treatment of patients with advanced renal cell carcinoma.
By adding bevacizumab (Avastin) to a standard chemotherapy doublet, the risk of death is reduced by 24%, with the risk of disease reducing by 39%, in patients who have malignant pleural mesothelioma (MPM).
The FDA recently granted alectinib a priority review designation for patients who have ALK-positive, locally advanced or metastatic non-small cell lung cancer (NSCLC) and progressed or are intolerant to crizotinib (Xalkori).
Nivolumab (Opdivo) was given a priority review designation by the FDA for patients with previously treated nonsquamous non-small cell lung cancer (NSCLC).
Rolapitant (Varubi) was recently approved by the FDA for use in combination with other antiemetic agents, in order to prevent delayed CINV from initial and repeat chemotherapy regiments, including highly emetogenic chemotherapy.
Elotuzumab (Empliciti) was recently granted a priority review by the FDA for use in combination therapy in patients who have multiple myeloma, following the failure of one or more prior therapies.
An application for afatinib (Gilotrif) was recently accepted by the FDA for the treatment of patients with squamous cell non-small cell lung cancer (NSCLC).
Cabozantinib (Cometriq) was given a breakthrough therapy designation by the FDA for the treatment of patients who have advanced renal cell carcinoma (RCC), following one prior therapy.
Sonidegib (Odomzo) was approved by the EC for the treatment of patients who have locally advanced basal cell carcinoma (laBCC) and are not amenable to curative surgery or radiation therapy.
Pembrolizumab (Keytruda) has received priority review from the US Food and Drug Administration (FDA) as frontline treatment for patients with advanced melanoma.
While targeting HER2 mutations is mainly associated with breast cancer, there could be therapeutic potential with anti-HER2 agents in non-small cell lung cancer (NSCLC).
Precision medicine with TKIs and immunotherapies is revolutionizing the treatment of patients with NSCLC. Paul A. Bunn, Jr, MD, head of the Division of Medical Oncology at the University of Colorado, discussed the current translational advances with these agents in a discussion held at this year’s International Lung Cancer Congress.
Hedgehog inhibitor sonidegib (Odomzo) was recently approved by the FDA for the treatment of patients who have locally advanced basal cell carcinoma (laBCC) that has recurred following surgery or radiation, or for those not eligible for these treatments.