Silas Inman

Venetoclax (ABT-199) monotherapy showed promising phase II results, which will be submitted to regulatory agencies for patients with relapsed or refractory chronic lymphocytic leukemia (CLL) harboring the 17p deletion.

Clinical trial designs are experiencing a huge transformation geared toward the discovery and confirmation of new predictive biomarkers for patients who have non-small cell lung cancer (NSCLC), as well as other types of solid tumors.

A new drug application (NDA) was recently submitted for rociletinib (CO-1686) as a treatment for patients who have EGFR T790M-positive metastatic non-small cell lung cancer (NSCLC) following previous administration of an EGFR TKI.

After a successful demonstration as single-agents, clinical trials are currently assessing PD-1 and PD-L1 inhibitors, combined with chemotherapy, targeted therapies, and radiation therapy, in an attempt to further improve outcomes for patients who have non-small cell lung cancer (NSCLC).

Next generation therapies proven to be highly effective, are in development for patients who have oncogene-driven non-small cell lung cancer (NSCLC), specifically those with alterations in EGFR, ALK, ROS1, and NTRK.

Pertuzumab (Perjeta), in combination with trastuzumab (Herceptin) and chemotherapy, was approved by the European Commission (EC) as a neoadjuvant therapy for adult patients who have HER2-positive, locally advanced, inflammatory, or early stage breast cancer and are at high risk of recurrence.

Lenvatinib (Lenvima) was recently granted a breakthrough therapy designation by the FDA as a potential treatment for patients with advanced renal cell carcinoma (RCC) who have received a VEGF-targeted therapy.

A supplemental new drug application (sNDA) was recently submitted for carfilzomib (Kyprolis) in combination with dexamethasone for patients who have relapsed multiple myeloma, following previous treatment with at least one therapy.

Breakthrough therapy designation has been granted by the US Food and Drug Adminstration (FDA) to the combination of the BRAF inhibitor dabrafenib (Tafinlar) and the MEK inhibitor trametinib (Mekinist) as treatment for patients with BRAF V600E-mutant non–small cell lung cancer

The PD-1 inhibitor pembrolizumab (Keytruda) was recently approved by the European Commission for the treatment of adult patients who have unresectable or metastatic melanoma in the first-line and previously treated settings, based on data from three clinical trials that evaluated the medication in over 1500 patients.

The anti-PDL1 agent, atezolizumab (MPDL3280A) may effectively shrink tumors in patients with locally advanced or metastatic urothelial bladder cancer in the second-line setting, according to a statement from the immunotherapy’s developer, Genentech.

Nivolumab (Opdivo) was recently approved by the European Commission as a treatment for patients who have locally advanced or metastatic squamous non-small cell lung cancer (NSCLC), following prior chemotherapy, based on findings from the phase III Checkmate-017, as well as the phase II Checkmate-063 trials.

A recent combined analysis of the BOLERO-1 and -3 studies showed that PIK3CA mutations and low/no expression of PTEN linked to an extension in progression-free survival (PFS) for patients who have metastatic HER2-positive breast cancer and are treated with a combination of everolimus, trastuzumab, and paclitaxel.

Results from the phase III METEOR study showed that treatment with cabozantinib (Cometriq) improved progression-free survival (PFS) and overall survival (OS) compared with everolimus (Afinitor) in previously treated patients with metastatic renal cell carcinoma (mRCC).

According to findings from a phase II study released by Amgen, monotherapy with blinatumomab (Blincyto) showed 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 (ALL).

The immunotherapy DPX-Survivac has been granted orphan drug designation as treatment ovarian cancer, based on early-phase research showing a robust immune response with the therapy in combination with low-dose cyclophosphamide.

Takeda released a statement saying that a new drug application was submitted for ixazomib (MLN9708), an oral proteasome inhibitor, used in combination with lenalidomide and dexamethasone, as a treatment for patients with relapsed and/or refractory multiple myeloma.

The approval of necitumumab, combined with gemcitabine and cisplatin for the first-line treatment of patients who have locally advanced or metastatic squamous non-small cell lung cancer (NSCLC), was supported by FDA’s Oncologic Drugs Advisory Committee (ODAC).

Patients with heavily pretreated colorectal cancer who harbored genetic defects in mismatch repair experienced high response rates when treated with the programmed cell death protein-1 inhibitor pembrolizumab (Keytruda), according to findings from an ongoing phase II study.

Patients with pretreated advanced ovarian cancer demonstrated encouraging signs of antitumor activity with monoclonal antibodies against programmed death-1 and its ligand PD-L1, according to findings from two clinical studies presented at the 2015 ASCO Annual Meeting.

Marking the first time a phase III study has shown a survival advantage for patients with soft tissue sarcoma, treatment with eribulin (Halaven) demonstrated improved overall survival (OS) by 2 months compared with dacarbazine in patients with advanced leiomyosarcoma (LMS) and adipocytic sarcoma (ADI).

Monotherapy with daratumumab demonstrated promising overall survival and objective response rates in patients with double-refractory multiple myeloma.

MPDL3280A reduced the risk of death by 53% compared with docetaxel in previously treated patients with PD-L1-positive squamous and non-squamous non-small cell lung cancer.

Enzalutamide significantly improved progression-free survival and PSA progression compared with bicalutamide in men with metastatic and non-metastatic castration-resistant prostate cancer.

Zarxio, the first FDA-approved biosimilar, has effectively been blocked from reaching US markets by an injunction from Amgen.

Topline findings from the phase III COMPLEMENT 2 study indicated that treatment with ofatumumab (Arzerra) plus fludarabine and cyclophosphamide significantly improved progression-free survival (PFS) compared with fludarabine and cyclophosphamide alone in patients with relapsed chronic lymphocytic leukemia (CLL).

Following the FDA fast track designation in November 2014, Merrimack Pharmaceuticals and Baxter International have completed the submission of a new drug application for MM-398 in combination with 5-fluorouracil and leucovorin, according to a statement from the drug's developers.

The FDA has issued a label update for pomalidomide (Pomalyst) plus low-dose dexamethasone to include data from the phase III MM-003 study.

The FDA has approved second-line ramucirumab (Cyramza) in combination with FOLFIRI as a treatment for patients with metastatic colorectal cancer (mCRC) following progression on a first-line bevacizumab-containing regimen.

The PD-L1 inhibitor MPDL3280A demonstrated a 19% objective response rate (ORR) with 75% of responses ongoing in pretreated patients with metastatic triple-negative breast cancer (TNBC).