Silas Inman

The anti-CD19 chimeric antigen receptor (CAR)-modified T-cell therapy CTL019 demonstrated a 92% complete response (CR) rate in pediatric patients with relapsed/refractory acute lymphoblastic leukemia (ALL).

The FDA has approved ruxolitinib as a treatment for patients with polycythemia vera who are resistant or intolerant to hydroxyurea

The anti-CD19 immunotherapy blinatumomab (Blincyto) has been approved by the FDA as a treatment for patients with Philadelphia chromosome-negative relapsed/refractory B-precursor acute lymphoblastic leukemia (ALL), based on findings from a phase II trial.

Pfizer and Merck KGaA will collaborate on the development of the PD-L1 inhibitor MSB0010718C as a potential treatment for multiple types of cancer, according to the companies.

The FDA has granted the chimeric antigen receptor (CAR) T cell therapy JCAR015 a breakthrough therapy designation as a treatment for patients with relapsed or refractory B-cell acute lymphoblastic leukemia (ALL).

MM-398 (nal-IRI) plus 5-fluorouracil (5-FU) and leucovorin received a Fast Track designation from the FDA as a second-line treatment for patients with metastatic pancreatic cancer.

Pembrolizumab (Keytruda) significantly improved progression-free survival (PFS) by over 43% compared with chemotherapy as a treatment for patients with metastatic melanoma who were refractory to ipilimumab (Yervoy).

Frontline treatment with nivolumab (Opdivo) significantly extended overall survival (OS) and progression-free survival (PFS) when compared with dacarbazine in patients with untreated BRAF wild-type advanced melanoma.

Bevacizumab (Avastin) has been approved for patients with recurrent platinum-resistant ovarian cancer in combination with chemotherapy. The approval was based on results from the phase III AURELIA trial.

Frontline treatment with neratinib and paclitaxel demonstrated similar ORR and PFS as trastuzumab and paclitaxel while lowering the incidence of CNS metastases in patients with locally recurrent or metastatic HER2-positive breast cancer.

Bayer HealthCare Pharmaceuticals restored access to radium-223 dichloride (Xofigo) following a temporary suspension in production to adjust its manufacturing process to meet certain quality standards that the company has in place.

The FDA’s Oncologic Drugs Advisory Committee (ODAC) voted 5-2 against the accelerated approval of panobinostat (Farydak) in combination with bortezomib (Velcade) and dexamethasone for the treatment of patients with multiple myeloma who have received at least one prior therapy.

Adding the GM-CSF agent sargramostim to the CTLA-4 inhibitor ipilimumab (Yervoy) prolonged overall survival (OS) and lowered toxicity for patients with unresectable stage III or IV melanoma.

Based on data from the phase III RAINBOW trial, the FDA has approved ramucirumab (Cyramza) in combination with paclitaxel as a treatment for patients with previously treated advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma.

A statistically significant improvement in overall survival (OS) was not seen with the combination of paclitaxel and the angiogenesis inhibitor trebananib when compared with paclitaxel alone for patients with recurrent platinum-resistant ovarian cancer.

TAS-102 (tipiracil hydrochloride) has received a fast track designation from the FDA as a treatment for patients with refractory metastatic colorectal cancer (mCRC), according to an announcement by Taiho Oncology, the company developing the drug in the US.

The FDA has granted a priority review to the oral multiple tyrosine kinase receptor inhibitor lenvatinib as a treatment for patients with progressive, radioactive iodine (RAI)-refractory differentiated thyroid cancer (DTC).

The FDA has assigned a priority review designation to palbociclib in combination with letrozole as a frontline treatment for postmenopausal patients with ER-positive, HER2-negative advanced breast cancer.

The FDA has approved bortezomib (Velcade) in combination with rituximab, cyclophosphamide, doxorubicin, and prednisone (VR-CAP) as a frontline treatment for patients with mantle cell lymphoma.

The FDA has assigned a priority review designation to blinatumomab as a treatment for adult patients with Philadelphia chromosome-negative (Ph-) relapsed/refractory B-precursor acute lymphoblastic leukemia.

The FDA has scheduled an ODAC advisory hearing to discuss the NDA for panobinostat in combination with bortezomib and dexamethasone for patients with multiple myeloma who have received at least one prior therapy.

Several clinical trials combining nivolumab (Opdivo) with targeted therapies against ALK, c-MET, and T790M for patients with non-small cell lung cancer (NSCLC) have been established as part of a collaboration between Novartis and Bristol-Myers Squibb (BMS).

The highly selective ALK inhibitor AP26113 has been granted a Breakthrough Therapy Designation by the FDA for the treatment of patients with ALK-positive metastatic NSCLC who received prior treatment with crizotinib.

The FDA has assigned a priority review designation to nivolumab for pretreated patients with advanced melanoma, setting an action date for the drug as March 30, 2015.

High pretreatment levels of serum VEGF-A and TGF-β1 indicated significantly worse disease-free survival (DFS) following neoadjuvant chemoradiotherapy in patients with esophageal squamous cell carcinoma.

The combination of ramucirumab and FOLFIRI significantly improved overall survival and progression-free survival compared with chemotherapy alone as a second-line treatment for patients with mCRC.

The FDA has expanded the approval for enzalutamide (Xtandi) to include the treatment of men with chemotherapy-naive metastatic castration-resistant prostate cancer (mCRPC).

The combination of multiple independent factors minimized the impact of baseline stage for predicting locoregional recurrence (LRR) following neoadjuvant chemotherapy in patients with breast cancer.

Cabozantinib (Cometriq) failed to significantly extend overall survival (OS) compared with prednisone as a treatment for men with metastatic castration-resistant prostate cancer (mCRPC).

The FDA has approved eltrombopag (Promacta) as a treatment for patients with severe aplastic anemia (SAA) following an insufficient response to immunosuppressive therapy, based on data from an open-label, single-arm phase II trial.