Silas Inman

A combination of dabrafenib and trametinib has been approved by the FDA for patients with unresectable or metastatic BRAF-mutated melanoma, based on an extension in overall survival (OS) from two phase III studies.

Patients receiving a combination of MEK inhibitor trametinib and BRAF inhibitor dabrafenib not only greatly improves long-term outcomes, but also lowers some adverse events associated with either standalone agent for patients with BRAF-mutated metastatic melanoma.

Avelumab has been given breakthrough therapy designation by the FDA as a possible treatment for patients with metastatic Merkel cell carcinoma (MCC) following progression on at least one prior chemotherapy regimen

The PD-1 inhibitor nivolumab (Opdivo) has gained a priority review status from the FDA as a treatment for patients with advanced renal cell carcinoma (RCC) following prior antiangiogenic therapy.

The FDA has given osimertinib (Tagrisso, AZD9291) an accelerated approval for treatment of patients with advanced EGFR T790M mutation-positive non-small cell lung cancer (NSCLC) following progression on a prior EGFR TKI.

While immune checkpoint inhibitors initially showed promise in patients with ovarian cancer, results still need to be validated by larger randomized trials.

Immune checkpoint inhibitors have emerged with encouraging results in patients with small cell lung cancer (SCLC) and mesothelioma

Monoclonal antibodies, specifically the CD3 and CD19 bispecific agent blinatumomab (Blincyto) and the CD22-targeted antibody-drug conjugate inotuzumab ozogamicin, are set to overhaul the treatment of adults with relapsed acute lymphoblastic leukemia.

Pexidartinib (formerly PLX3397) has been granted a breakthrough therapy designation by the FDA based on findings from a phase I study published in The New England Journal of Medicine.

The FDA has granted breakthrough therapy designation to Pembrolizumab (Keytruda) as a potential therapy for patients with microsatellite instability-high metastatic colorectal cancer.

The FDA has approved MM-398 in combination with 5-fluorouracil and leucovorin as a treatment for patients with metastatic pancreatic cancer.

The anti-CD22 antibody-drug conjugate inotuzumab ozogamicin has been granted breakthrough therapy designation by the FDA as a potential treatment for relapsed or refractory acute lymphoblastic leukemia patients.

The CDK4/6 inhibitor abemaciclib (LY2835219) has been granted FDA breakthrough therapy designation as monotherapy for heavily pretreated patients with refractory hormone-receptor-positive advanced breast cancer.

Optune (NovoTTF-100A) in combination with adjuvant temozolomide has received FDA approval as a treatment for patients with newly diagnosed glioblastoma multiforme following surgery, chemotherapy, and radiation therapy.

Telesta Therapeutics has been granted an FDA advisory hearing to discuss the biologics license application of its MCNA immunotherapy as treatment for high-risk nonmuscle invasive bladder cancer following first-line bacillus Calmette-Guerin (BCG).

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)