Silas Inman

Articles by Silas Inman

FDA Grants Durvalumab Breakthrough Status for Bladder Cancer

Published: | Updated:

The FDA has granted a breakthrough therapy designation to durvalumab as a treatment for patients with PD-L1 positive inoperable or metastatic urothelial bladder cancer following progression on prior treatment with a platinum-based regimen.

FOLFOXIRI Bests FOLFOX as Bevacizumab Backbone in mCRC

Published: | Updated:

Marginal improvements were seen in clinical outcomes for patients with metastatic colorectal cancer (CRC) treated with FOLFOXIRI plus bevacizumab compared with FOLFOX plus bevacizumab; however, these findings were inconsistent, according to results from the phase II STEAM trial.

Full Clinical Hold Announced by FDA for Pacritnib

Published: | Updated:

The FDA has announced a full clinical hold for trials exploring pacritinib following reports of patient deaths. These deaths stemmed from intracranial hemorrhage, cardiac failure, and cardiac arrest in the phase III PERSIST-2 trial.

Nivolumab Boosts OS in Phase III in SCCHN Study

Published: | Updated:

Anti–PD-1 agent nivolumab boosted overall survival versus an investigator's choice of therapy in platinum-refractory squamous cell carcinoma of the head and neck (SCCHN) during a recent trial.

Clinical Review: Regorafenib in Refractory mCRC

Published: | Updated:

"While adverse events across both populations were broadly similar, some did occur more frequently in patients with longer exposure, an observation that is possibly related to the longer duration in this subgroup," said Axel Grothey, MD.

The second interim analysis of the phase III METEOR trial has revealed a statistically significant improvement in overall survival (OS) with cabozantinib (Cometriq) versus everolimus (Afinitor) as a treatment for patients with advanced renal cell carcinoma (RCC) following progression on one prior therapy, according to a statement from the drug's developer, Exelixis.

Eribulin Approved by FDA for Treatment of Advanced Liposarcoma

Published: | Updated:

The FDA has approved eribulin mesylate (Halaven) as a treatment for patients with advanced or unresectable liposarcoma following prior treatment with an anthracycline-based chemotherapy, based on an improvement in overall survival (OS) in a phase III study.

Hypofractionated Radiotherapy Noninferior to Standard Radiation Therapy

Published: | Updated:

Hypofractionated radiotherapy and standard radiation therapy demonstrated similar toxicities and neither prevented PSA increases or disease recurrences for men with intermediate-risk prostate cancer better than the other, according to data from the phase III randomized CHHiP trial reported at the 2016 GU Cancers Symposium.

European Commission Approves T-VEC for Unresectable Metastatic Melanoma

Published: | Updated:

Talimogene laherparepvec (T-VEC; Imlygic) has been approved by the European Comission as a treatment for adult patients with unresectable stage IIIb, IIIc, and IVM1a melanoma that has not spread to the bone, brain, lung, or other viscera, based on the phase III OPTiM study.

Decision on Rociletinib for NSCLC Delayed by FDA

Published: | Updated:

The review period for rociletinib for EGFR T790M-positive non-small cell lung cancer (NSCLC) has been extended by the FDA by 3 months. The extension allows ample time to review additional data submitted by the drug's developer, Clovis Oncology.

Elotuzumab Benefits Level Out in 3-Year Myeloma Data

Published: | Updated:

A triplet of elotuzumab, lenalidomide, and dexamethasone produced sustained improvements in both progression-free survival and overall survival in patients with relapsed/refractory multiple myeloma, according to a 3-year analysis of the phase III ELOQUENT-2 trial.