Jason M Broderick

Two trials testing Gilotrif's efficacy in head and neck cancer were stopped after a panel decided it was unlikely the drug would prove beneficial.

“Urothelial cancer is a common type of bladder cancer where patients experience high rates of recurrence and remains an area where new treatment approaches are needed, further underscoring the importance of this designation for Opdivo,” said Jean Viallet.

Two studies showed that Jakafi has high response rates with patients with GVHD, making the FDA give the drug a breakthrough therapy designation.

A phase 3 trial showed that Keytruda has better overall survival rates for NSCLC than chemotherapy.

The combination of Opdivo and Yervoy showed promise for certain patients with colorectal cancer in a phase 2 study.

A phase 3 study showed improved survival rates for patients with high-risk, secondary AML who took Vyxeos.

Opdivo continues to demonstrate improved overall survival in lung cancer.

A phase 3 study showed that adding Ibrance to Femara reduces disease progression for patients with ER-positive, HER2-negative advanced or metastatic breast cancer.

Previously treated patients with advanced renal cell carcinoma saw a higher overall survival rate with Cabometyx when compared to those on Afinitor, according to a phase 3 study.

The location of colon cancer may have a say in survival, according to a recent analysis.

Based on data from a phase 2 study, Tecentriq (atezolizumab), a PD-L1 inhibitor, was granted an accelerated approval for patients with locally advanced or metastatic urothelial carcinoma.

The FDA approved Opdivo (nivolumab) for classical Hodgkin lymphoma (cHL).

Algenpantucel-L failed to improve OS for patients with pancreatic cancer in a phase 3 trial.

The FDA expanded the label for Imbruvica for some patients with CLL, as the drug continues to show improved survival benefits.

Stivarga (regorafenib) proved to have better overall survival for patients with HCC in a recent phase 3 trial.

The FDA granted olaratumab a priority review for some people with advanced soft tissue sarcoma (STS).

The FDA granted Blincyto a priority review for certain pediatric patients with ALL.

The FDA approved Cabometyx (cabozantinib) for patients with advanced renal cell carcinoma (RCC) who have received prior antiangiogenic therapy.

Gilotrif (afatinib) recently gained approval for some patients with non–small cell lung cancer (NSCLC).

According to an analysis of the phase 3 GOG-0218 trial, patients who had ovarian cancer and mutations in homologous recombination (HR) genes showed improved survival rates when compared to patients without the mutations.

Opdivo might be the first PD-1 inhibitor approved for a hematologic malignancy after FDA review and approval.

FDA’s Oncologic Drugs Advisory Committee (ODAC) ultimately voted against the accelerated approval of rociletinib for patients with metastatic EGFR T790M–mutated non–small cell lung cancer (NSCLC) who have previously received an EGFR-targeted therapy.

After multiple clinical trials, atezolizumab was granted a priority review by the FDA. A decision is expected this fall.

The FDA approved Venclexta for patients with CLL who have a 17p deletion and failed at least one prior therapy.

Although there were no major changes to the 2016 update to the National Comprehensive Cancer Network (NCCN) Breast Cancer Guidelines, there were some “tweaks.”

The approval was based on results from a multicenter, open-label phase 2b study in which the overall response rate with Evomela was 95 percent among 61 patients.

Emotional support can have a huge impact on breast cancer treatment.

In the phase 3 RESONATE-2 study, Imbruvica improved progression-free survival (PFS) by 84 percent in previously untreated patients with CLL or SLL.

The approval is based on the phase 3 GADOLIN study, in which Gazyva plus bendamustine followed by Gazyva alone reduced the risk of disease progression by 52 percent in patients with follicular lymphoma.