Silas Inman

The CD38 monoclonal antibody Darzalex demonstrated a 31 percent overall response rate as monotherapy for patients with heavily pretreated multiple myeloma.

An all orally administered regimen containing Ninlaro, Revlimid and dexamethasone showed a 5.9-month improvement in progression-free survival compared with Revlimid and dexamethasone alone.

The agent was approved as a treatment for patients with metastatic ALK-positive non-small cell lung cancer (NSCLC).

After a median follow-up of 10 months, the overall response rate in patients with PD-L1-expressing metastatic breast cancer was 33.3 percent.

In updated data from a phase 3 study, the addition of Empliciti reduced the risk of progression or death by 27 percent.

The treatment paradigm for patients with triple-negative breast cancer is set to undergo a dramatic transformation, as standard chemotherapeutic approaches are perfected and novel antibody-drug conjugates are developed.

When tyrosine kinase inhibitors benefit patients with CML, can treatment ever be stopped? Experts are looking for an answer.

The approval was based findings from the phase 3 SQUIRE trial.

The approval was based on a substantial improvement in overall survival (OS) in a phase 3 study.

The approval was based on an extension in overall survival (OS) in the CheckMate-025 trial.

The approval was based on an extension in overall survival from two phase 3 studies.

The FDA has approved the oral medication Ninlaro in combination with Revlimid and dexamethasone for patients with multiple myeloma.

Immune checkpoint inhibitors have demonstrated encouraging results for patients with small cell lung cancer (SCLC) and mesothelioma, two aggressive thoracic malignancies with few options.

A phase 3 study exploring Zydelig in combination with Treanda and Rituxan for patients with previously treated CLL has been stopped early following a positive interim analysis.

Adding the MEK inhibitor Mekinist to the BRAF inhibitor Tafinlar significantly improves long-term outcomes while lowering certain adverse events associated with either agent alone.

As part of this program, the FDA plans to take action on the drug's application within six months instead of the standard 10 months under regular review.

The approval was based on data from two open-label clinical trials.

The approval was based on data from 411 patients from two single-arm studies.

Monoclonal antibodies are poised to revolutionize the treatment of adult patients with relapsed acute lymphoblastic leukemia (ALL).

The approval was based on an extension in progression-free survival in the phase 3 coBRIM study.

"It's not because there's evidence that they don't work — it's just that there's no evidence at all," Maurie Markman says.

The designation, which will expedite the development and review of Keytruda in this space, was based on findings from an ongoing phase 2 study.

The approval was based on data from the phase 3 NAPOLI-1 trial, which demonstrated a 1.9-month improvement in overall survival (OS) with the addition of Onivyde to 5-FU and leucovorin.

The American Cancer Society has updated its breast cancer screening guideline to recommend that woman at an average risk of breast cancer should wait to undergo annual screening mammography until they reach the age of 45.

The agent gained a priority review designation for use in combination with dexamethasone for patients with relapsed multiple myeloma following prior treatment with at least one therapy, based on findings from the phase 3 ENDEAVOR trial.

The approval was based on findings from the phase 3 EF-14 trial.

The combination was approved for patients with BRAF V600 wild-type unresectable or metastatic melanoma, based on results from a phase 2 study.

At an 18-month analysis, the overall survival rate with the PD-1 inhibitor was 28 percent versus 13 percent with docetaxel in previously treated patients with squamous NSCLC.

Researchers are gaining new insight into long-term aspirin use for the prevention of colorectal cancer.

Overregulation of new drug development has driven up the cost of care and resulted in significant loss of human life by delaying the approval of effective medications, according to David J. Stewart.