Silas Inman

A new drug application (NDA) has been submitted to the FDA for telotristat etiprate as a treatment for carcinoid syndrome in patients with metastatic neuroendocrine tumors (NETs), according to a statement from the drug's developer, Lexicon Pharmaceuticals.

The FDA has approved defibrotide sodium (Defitelio) as a treatment for severe hepatic veno-occlusive disease (VOD) with associated kidney or lung abnormalities following hematopoietic stem cell transplantation (HSCT), based on data from the collection of 3 studies.

Liposomal irinotecan (irinotecan liposome injection; Onivyde), fluorouracil (5-FU), and leucovorin in combination has been added to the 2016 NCCN Clinical Practice Guidelines in Oncology as a second-line treatment for patients with gemcitabine-refractory metastatic pancreatic cancer.

Trabectedin (Yondelis) improved progression-free survival (PFS) when compared with dacarbazine in women with advanced uterine leiomyosarcoma, according to a subgroup analysis of the phase III SAR-3007 trial.

An abiraterone acetate (Zytiga) plus prednisone combination showcased an 11.8-month improvement in overall survival (OS) when compared with prednisone and placebo in less advanced, chemotherapy-naive metastatic castration-resistant prostate cancer.

Captisol-enabled (CE) melphalan (Evomela) has been approved by the FDA as a high-dose conditioning treatment for patients with multiple myeloma prior to autologous stem cell transplantation (ASCT).

The PD-L1 inhibitor atezolizumab has gained priority review status from the FDA as a treatment for patients with locally advanced or metastatic urothelial carcinoma (mUC).

Six ongoing clinical trials investigating several idelalisib (Zydelig) combinations have been halted due to reports of increased adverse events such as death for patients with hematologic malignancies, according to an alert issued by the FDA.

The FDA has recieved a supplemental new drug application for a combination of ofatumumab (Arzerra), fludarabine, and cyclophosphamide, for patients with relapsed chronic lymphocytic leukemia (CLL).

The addition of Yttrium-90 (Y-90) resin microspheres (SIR-Spheres) to standard frontline FOLFOX-based chemotherapy with or without bevacizumab significantly improved liver-specific progression-free survival (PFS) for patients with liver metastatic colorectal cancer (CRC), according to findings from the phase III SIRFLOX study published in the Journal of Clinical Oncology.

Crizotinib (Xalkori) has been approved by the FDA for patients with ROS1-positive metastatic non-small cell lung cancer (NSCLC), based on substantial efficacy displayed in a phase I study.

A supplemental new drug application for pembrolizumab for advanced non-small cell lung cancer (NSCLC) with PD-L1 expression on ≥1% of tumors cells has been submitted to the FDA.

The combination of rindopepimut plus temozolomide did not improve overall survival (OS) when compared with temozolomide plus a control in patients with newly diagnosed EGFRvIII-positive glioblastoma multiforme (GBM).

Tremelimumab as a monotherapy in both the second- and third-line treatment failed to boost overall survival (OS) compared with placebo for patients with unresectable malignant mesothelioma.

In the study, the bavituximab combination showed OS data similar to expectations while patients in the docetaxel-alone arm "dramatically outperformed OS expectations," according to Peregrine Pharmaceuticals.

The 5-year overall survival (OS) in elderly patients with locally advanced head and neck cancers was drastically improved with concurrent chemoradiation versus radiation therapy alone, according to an analysis of the National Cancer Data Base.

The FDA has handed down a breakthrough therapy designation for midostaurin (PKC412) as a potential treatment for adults with newly diagnosed FLT3-mutated acute myeloid leukemia (AML).

Complimenting best supporting care with panitumumab dropped the risk of death by 30% for patients with RAS wild-type chemorefractory metastatic colorectal cancer (mCRC).

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.

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.

The FDA has scheduled an Oncologic Drugs Advisory Committee (ODAC) advisory hearing for April 12 to review the new drug application for rociletinib, a treatment for metastatic EGFR T790-mutated non-small cell lung cancer.

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.

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.

"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.

Cabozantinib (Cometriq) has receieved a priority review designation from the FDA for patients with advanced renal cell carcinoma (RCC) following progression on one prior therapy, according to Exelixis, the drug's developer.

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.

Pembrolizumab (Keytruda), a PD-1 inhibitor, showcased encouraging activity with some adverse events (AEs) when employed as a treatment for patients with advanced PD-L1

Combining liposomal irinotecan (nal-IRI; MM-398; Onivyde) with 5-fluorouracil (5-FU) plus leucovorin dropped the risk of death in patients with metastatic pancreatic cancer by 25% following progression on a gemcitabine-based regimen, according to updated data from the phase III NAPOLI-1 trial.

Preoperative treatment with short-course radiation therapy plus 3 cycles of chemotherapy boosted overall survival (OS) and generated fewer adverse events (AEs) compared to standard chemoradiation for patients with locally advanced rectal cancer.