News
- Author:
- Laura Nikolaides
Publish date: March 29, 2018
FDA grants accelerated approval to treat patients with B-cell precursor ALL who are in remission but still have minimal residual disease.
News
- Author:
- Laura Nikolaides
Publish date: March 6, 2018
The test identifies the three most common BRCA1/2 mutations among people of Ashkenazi Jewish descent.
News
- Author:
- Laura Nikolaides
Publish date: February 14, 2018
This is the first FDA approval based on the endpoint of metastasis-free survival.
News
- Author:
- Laura Nikolaides
Publish date: February 8, 2018
The approval expands on the previous indication for use in combination with prednisone for treatment of metastatic castration-resistant prostate ca...
News
- Author:
- Laura Nikolaides
Publish date: January 17, 2018
The application for tisagenlecleucel suspension is based on results from the phase 2 JULIET trial.
News
- Author:
- Laura Nikolaides
Publish date: January 12, 2018
This is the first FDA approval of a PARP inhibitor to treat breast cancer and the first approval for treatment of patients with metastatic breast c...
News
- Author:
- Laura Nikolaides
Publish date: December 21, 2017
Approval was based on a 52% reduction in rate of disease progression when compared with treatment with sunitinib.
News
- Author:
- Laura Nikolaides
Publish date: December 4, 2017
The Food and Drug Administration has approved trastuzumab-dkst (Ogivri) as a biosimilar to trastuzumab (Herceptin) for the treatment of patients wi...
News
- Author:
- Laura Nikolaides
Publish date: December 1, 2017
The Food and Drug Administration has approved trastuzumab-dkst (Ogivri) as a biosimilar to trastuzumab (Herceptin) for the treatment of patients wi...
News
- Author:
- Laura Nikolaides
Publish date: November 28, 2017
Dr. Silvia Formenti of Weill Cornell Medicine will outline her ongoing clinical work to combine RT with immune checkpoint inhibitors to evoke T-cel...
News
- Author:
- Laura Nikolaides
Publish date: November 17, 2017
Sunitinib malate is the first adjuvant treatment approved for patients with renal cell carcinoma.
News
- Author:
- Laura Nikolaides
Publish date: November 14, 2017
Approval was based on complete cytogenetic response data from 97 pediatric patients with chronic phase CML evaluated in two nonrandomized trials.
News
- Author:
- Laura Nikolaides
Publish date: November 9, 2017
Approval was based on a 56% objective response rate for brentuximab vedotin vs. 12% for physician’s choice of methotrexate or bexarotene in a phase...
News
- Author:
- Laura Nikolaides
Publish date: October 31, 2017
Approval was based on an 81% overall response rate in a phase 2 trial of 124 patients who had received at least one prior therapy.
News
- Author:
- Laura Nikolaides
Publish date: September 28, 2017
The indication for the CDK4/6 inhibitor includes treatment in combination with fulvestrant and as a single agent.
