Silas Inman

Clinical trial designs are undergoing a dramatic transformation geared toward the discovery and validation of new predictive biomarkers.

A number of clinical trials are now assessing PD-1 and PD-L1 inhibitors in combination with chemotherapy, targeted therapies, and radiation therapy in an attempt to further improve outcomes for patients with non–small cell lung cancer.

Highly effective next-generation therapies are currently in development for patients with oncogene-driven non–small cell lung cancer, specifically those with alterations in EGFR, ALK, ROS1, NTRK, or a variety of other gene.

The European Commission has approved the combination of pertuzumab, trastuzumab, and chemotherapy as a neoadjuvant therapy for adult patients with HER2-positive, locally advanced, inflammatory, or early stage breast cancer who are at high risk of recurrence.

An application has been submitted to the FDA for eribulin mesylate (Halaven) as a treatment for patients with soft tissue sarcoma following an anthracycline and at least one other regimen.

The utilization of idelalisib increased substantially between the first and second quarters of 2015, representing promising growth in a highly competitive setting.

Novel combination approaches are currently under exploration that hope to capitalize on the varying mechanisms of action for each newly approved agent for men with metastatic castration-resistant prostate cancer.

The FDA has granted a breakthrough therapy designation to lenvatinib as a potential treatment for patients with advanced renal cell carcinoma who have received a VEGF-targeted therapy.

The FDA has assigned a priority review designation to the combination of dabrafenib and trametinib for patients with unresectable or metastatic BRAFV600 mutation-positive melanoma.

A supplemental biologics license application has been submitted to the FDA for ofatumumab as a maintenance therapy in patients with relapsed chronic lymphocytic leukemia following a response to second- or third-line therapy.

A supplemental new drug application has been submitted for carfilzomib (Kyprolis) in combination with dexamethasone for patients with relapsed multiple myeloma following prior treatment with at least one therapy.

The FDA has granted a breakthrough therapy designation to the combination of the BRAF inhibitor dabrafenib and the MEK inhibitor trametinib as a potential treatment for patients with BRAFV600E-mutant non-small cell lung cancer.

Treatment with the combination of selumetinib and dacarbazine failed to improve progression-free survival compared with dacarbazine alone in patients with metastatic uveal melanoma.

The European Commission has approved the PD-1 inhibitor pembrolizumab as a treatment for adult patients with unresectable or metastatic melanoma in the first-line and previously treated settings.

An appellate court ruled that the FDA-approved biosimilar Zarxio can be marketed in the United States after September 2, 2015.

The European Commission has approved nivolumab as a treatment for patients with locally advanced or metastatic squamous non–small cell lung cancer following prior chemotherapy.

Treatment with cabozantinib improved progression-free survival and overall survival compared with everolimus in pretreated patients with metastatic renal cell carcinoma.

The FDA has granted an orphan drug designation to the immunotherapy DPX-Survivac as a treatment for women with ovarian cancer.

Monotherapy with blinatumomab has demonstrated promising complete remission (CR) or CR with partial hematological recovery (CRh) rates in adult patients with relapsed or refractory Philadelphia chromosome-positive (Ph+) B-cell precursor acute lymphoblastic leukemia.

PIK3CA mutations and low/no expression of PTEN correlated with an extension in progression-free survival for patients with metastatic HER2-positive breast cancer treated with the combination of everolimus, trastuzumab, and paclitaxel.

A new drug application has been submitted for the oral proteasome inhibitor ixazomib in combination with lenalidomide and dexamethasone as a treatment for patients with relapsed and/or refractory multiple myeloma

A collection of early phase clinical trials presented at the 2015 ASCO Annual Meeting demonstrated promising results for several novel agents in combination with established treatments for patients with hepatocellular carcinoma.

Second-line treatment with atezolizumab (MPDL3280A) has met the primary endpoint of a pivotal phase II study by effectively shrinking tumors in patients with locally advanced or metastatic urothelial bladder cancer.

ODAC supported the approval of necitumumab in combination with gemcitabine and cisplatin for the first-line treatment of patients with locally advanced or metastatic squamous non–small cell lung cancer.

Adding an NK1 antagonist to a 5-HT3 receptor antagonist with dexamethasone improved antiemetic control for patients with colorectal cancer treated with an oxaliplatin-based regimen compared with the 5-HT3 antagonist and dexamethasone alone.

Rolling submission of a new drug application for rociletinib has been initiated for patients with EGFR T790M-positive metastatic non–small cell lung cancer following prior treatment with an EGFR-targeted therapy.

The FDA has extended the review period for the MEK inhibitor cobimetinib in combination with the BRAF inhibitor vemurafenib (Zelboraf) for patients with BRAFV600 mutation-positive advanced melanoma by 3 months, making the new decision date November 11, 2015.

Celgene has entered into a 10-year collaboration with the cellular immunotherapy company Juno Therapeutics, which includes an initial $1 billion payment.

The FDA has assigned a priority review designation to MM-398 in combination with 5-fluorouracil and leucovorin for patients with metastatic pancreatic cancer following treatment with a gemcitabine-based therapy.

Chemotherapy-free neoadjuvant treatment with trastuzumab emtansine demonstrated a pathological complete response rate of 40.5% in patients with HER2+ and HR+ early breast cancer.