Silas Inman

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.

A New Drug Application has been submitted to the FDA for palbociclib plus letrozole as a frontline treatment for postmenopausal women with ER-positive, HER2-negative advanced breast cancer.

The FDA has approved bevacizumab in combination with paclitaxel and cisplatin or paclitaxel and topotecan as a treatment for patients with persistent, recurrent, or metastatic cervical cancer, based on the improvement in OS in the phase III GOG 240 study.

Treatment with single-agent carfilzomib (Kyprolis) was unable to significantly extend overall survival (OS) compared with best supportive care in heavily pretreated patients with multiple myeloma.

Significantly extended overall survival (OS) and progression-free survival (PFS) was seen with oral nucleoside TAS-102 treatment in patients with metastatic colorectal cancer (mCRC) refractory to standard therapies.

The FDA has approved Cologuard as the first noninvasive stool-based DNA test for the detection of CRC in asymptomatic individuals at average risk, based on clinical trial results demonstrating superiority to the fecal immunochemical test.

The FDA has expanded the bortezomib (Velcade) label to allow for retreatment in patients with multiple myeloma who previously responded to the proteasome inhibitor.

Women harboring a loss-of-function mutation in the PALB2 gene demonstrated an increased risk of developing breast cancer that was similar to the predisposition seen with mutations in BRCA.

The FDA has assigned a priority review designation to the JAK1/2 inhibitor ruxolitinib as treatment for patients with polycythemia vera who are resistant or intolerant to hydroxyurea.

The combination of carfilzomib, carfilzomib, and low-dose dexamethasone extended PFS by 8.7 months compared with lenalidomide and dexamethasone alone for patients with relapsed multiple myeloma.

The FDA has expanded the approval of ibrutinib (Imbruvica) to include the treatment of patients with chronic lymphocytic leukemia (CLL) who have received at least one previous therapy and harbor a 17p deletion.

Extended adjuvant treatment with neratinib (PB272, HKI-272) significantly improved disease-free survival (DFS) compared with placebo for patients with HER2-positive breast cancer who received prior adjuvant trastuzumab.