News

The FDA has approved nivolumab (Opdivo) for patients with unresectable or metastatic melanoma following treatment with ipilimumab or a BRAF inhibitor, based on data from the phase III CheckMate-037 trial.

The FDA has approved the PARP inhibitor olaparib (Lynparza) for the treatment of women with BRCA-positive advanced ovarian cancer.

Two HER2-targeting regimens anchored by T-DM1 failed to outperform the standard strategy in women with previously untreated advanced HER2-positive breast cancer, dealing a blow to efforts to move the drug into frontline settings.

The somatostatin analog lanreotide has gained FDA approval as a treatment for patients with unresectable, well or moderately differentiated, locally advanced or metastatic gastroenteropancreatic neuroendocrine tumors.

The FDA has approved the VEGFR-2 inhibitor ramucirumab (Cyramza) in combination with docetaxel for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumor has progressed during or following treatment with platinum-based chemotherapy.

Xgeva (denosumab) has received approval from the US Food and Drug Administration (FDA) for the treatment of hypercalcemia of malignancy (HCM) refractory to bisphosphonate therapy, and the agent was granted Orphan Drug Designation.

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).

Checkpoint inhibition has demonstrated efficacy for the treatment of melanoma in several clinical trials. However, biomarkers to predict safety and efficacy of immunotherapies in individual melanoma patients are lacking.

Ongoing clinical trials are evaluating a new immunotherapeutic approach for the treatment of malignant melanoma–the combination of an oncolytic virus with checkpoint inhibition.

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.

As its CAR T cell and high-affinity TCR products continue to advance in clinical trials, Juno Therapeutics, Inc, filed a registration statement for an initial public offering (IPO) of its common stock on November 17.

Knowledge of genetic expression of melanocytic lesions significantly reduced the number of indeterminate diagnoses made by dermatopathologists.

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.

Several novel approaches to the delivery of therapeutics for advanced melanoma may improve treatment efficacy and patient survival.

The monoclonal antibody cirmtuzumab, currently in clinical trials to treat CLL, targets ROR1 on the surface of cancerous B cells, and the agent may have a wider reach in the treatment of ovarian and other cancers.

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.

Recent news stories profiling a cancer patient whose last hope rests on treatment by injections of the virus that causes AIDS may have created some misconceptions regarding a new cancer immunotherapy.

Researchers from the Mayo Clinic in Jacksonville, Florida, have uncovered the link between oncogenic pancreatic acinar cells and the inflammation that facilitates its cancerous progression.

As new therapies enter the treatment landscape for metastatic disease, the role of the oncology nurse becomes even more critical in educating patients about what side effects to look out for and the importance of reporting any adverse events promptly.

Dendreon has filed for chapter 11 bankruptcy, the company announced Nov. 10. Dendreon is the maker of the first FDA-approved immunotherapy for advanced prostate cancer, sipuleucel-T (Provenge).

Drugs that inhibit the DNA repair enzyme poly(ADP-ribose) polymerase (PARP) have been shown to be effective in treating ovarian, breast, and prostate cancers in patients with inherited BRCA mutations.

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.