Silas Inman

Medivation has announced that it will purchase the PARP inhibitor talazoparib (BMN-673) from BioMarin Pharmaceutical for $410 million, with additional milestone and royalty payments of up to $160 million.

The FDA has approved eltrombopag as a treatment for pediatric patients with chronic immune thrombocytopenic purpura following a lack of response to other therapies or splenectomy.

The European Medicines Agency has accepted a marketing authorization application for ixazomib in combination with lenalidomide and dexamethasone for patients with relapsed/refractory multiple myeloma.

The FDA has approved the antibody-drug conjugate brentuximab vedotin as a consolidation therapy following autologous stem cell transplantation in patients with Hodgkin lymphoma who are at risk of relapse or progression.

The FDA has extended the review period for frontline nivolumab in patients with advanced melanoma by 3 months, to allow ample time to review additional data submitted by the PD-1 inhibitor's developer Bristol-Myers Squibb.

Treatment with single-agent venetoclax has met the primary endpoint of a pivotal phase II study for patients with relapsed or refractory chronic lymphocytic leukemia harboring the 17p deletion.

Frontline treatment with intraperitoneal chemotherapy is commonly underutilized for a majority of patients with optimally cytoreduced stage III ovarian cancer, despite recommendations for its use and a clear demonstration of improved overall survival.

Treatment with telotristat etiprate significantly reduced the average number of daily bowel movements compared with placebo for patients with carcinoid syndrome that was not adequately controlled with a somatostatin analog.

A new drug application has been submitted for rociletinib as a treatment for patients with EGFR T790M-positive metastatic non–small cell lung cancer following prior administration of an EGFR TKI.

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