Silas Inman

Eribulin mesylate (Halaven) has been granted an FDA priority review designation as a treatment for patients with advanced soft tissue sarcoma following chemotherapy.

The combination of nivolumab and ipilimumab has received accelerated FDA approval as a treatment for patients with BRAF V600 wild-type unresectable or metastatic melanoma.

Rociletinib has been granted priority review designation as a treatment for patients with EGFR T790M-mutant metastatic non-small cell lung cancer following prior administration of an EGFR TKI.

Dabrafenib (Tafinlar), in combination with trametinib (Mekinist), improved overall survival (OS) by 7.6 months, compared to the single-agent vemurafenib (Zelboraf) in patients who have unresectable or metastatic BRAFV600E/K-mutant melanoma.

Compared with everolimus, second-line treatment with cabozantinib (Cometriq) reduced the risk of progression or death by 42% in patients with advanced renal cell carcinoma (RCC)

Carfilzomib (Kyprolis) in combination with dexamethasone, was recently granted a priority review designation by the FDA for patients who have relapsed multiple myeloma, following prior treatment with at least one therapy.

AbbVie has submitted a supplemental new drug application for its BTK inhibitor ibrutinib (Imbruvica) as a therapy for treatment-naive patients with chronic lymphocytic leukemia (CLL) who are over the age of 65.

Coexisting driver mutations within EGFR-mutant non-small cell lung cancer (NSCLC) could possibly contribute to primary resistance to EGFR-targeted therapy.

Ixazomib (MLN9708), an oral proteasome inhibitor, was recently granted a priority review designation by the FDA, in combination with lenalidomide and dexamethasone for the treatment of patients who have relapsed and/or refractory multiple myeloma.

Daratumumab was recently assigned a priority review designation by the FDA as a treatment for patients who have multiple myeloma.

Zarxio (filgrastim-sndz), the first FDA-approved biosimilar, is now available for patients in the United States, after a series of court decisions and lawsuits.

A priority review designation was recently assigned by the FDA to the intravesical immunotherapy MCNA as a treatment for patients who have high-risk non-muscle invasive bladder cancer, following first-line bacillus Calmette-Guérin (BCG) therapy.

Eltrombopag (Promacta) was approved by the FDA for the treatment of pediatric patients with chronic ITP, following a lack of response to additional therapies or splenectomy.

The antibody-drug conjugate (ADC) brentuximab vedotin (Adcetris) was recently approved by the FDA as a consolidation therapy following autologous stem cell transplantation (ASCT) in patients who have Hodgkin lymphoma and are at risk of relapse or progression.

The review period for frontline nivolumab (Opdivo), in patients who have advanced melanoma, recently received an extension of three months by the FDA, in order to allow ample time for review of the additional data submitted by Bristol-Myers Squibb (BMS)

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).