Silas Inman

The FDA has granted a breakthrough therapy designation to the PARP1/2 inhibitor rucaparib for the treatment of women with BRCA-mutated advanced ovarian cancer.

The FDA has granted an accelerated approval to an oral suspension formulation of deferasirox (Jadenu) for the treatment of patients aged 2 and older with chronic iron overload due to multiple blood transfusions.

The FDA has updated the label for abiraterone acetate (Zytiga) plus prednisone to include data from the final analysis of the phase III COU-AA-302 study.

Combination therapy with ibrutinib plus bendamustine and rituximab significantly extended progression-free survival compared with BR alone in patients with chronic lymphocytic leukemia or small lymphocytic lymphoma enrolled in the phase III HELIOS trial.

Heterogeneity, which can result in treatment resistance, is commonly underestimated and misunderstood, representing an important area of future research.

While not appropriate for all patients with ER-positive breast cancer, neoadjuvant endocrine therapy could play an important role in select groups of women with comorbidities or those with ER-rich/luminal A disease.

Cytogenetic and molecular data are becoming increasingly important in the individualization of treatment of patients with acute myeloid leukemia (AML).

Dinutuximab (Unituxin) has been approved by the FDA in combination with interleukin-2, granulocyte-macrophage colony-stimulating factor (GM-CSF), and isotretinoin as a frontline therapy for pediatric patients with high-risk neuroblastoma.

Through a $21 billion acquisition of Pharmacyclics, AbbVie has announced plans to acquire the blockbuster BTK inhibitor ibrutinib (Imbruvica).

The FDA has approved panobinostat (Farydak) in combination with bortezomib (Velcade) and dexamethasone for patients with previously treated multiple myeloma.

Amgen and its subsidiary Onyx Pharmaceuticals have submitted an sNDA to the FDA for the full regulatory approval of carfilzomib (Kyprolis) as a treatment for patients with relapsed multiple myeloma.

The FDA has scheduled a hearing to discuss the biologics license application (BLA) for the immunotherapy talimogene laherparepvec (T-VEC) as a treatment for patients with metastatic melanoma.

Acting two months ahead of its deadline, the FDA granted an accelerated approval to palbociclib (Ibrance) as a first-line treatment for patients with ER-positive metastatic breast cancer.

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.

Fulvestrant (Faslodex) improved overall survival (OS) by 5.7 months compared with anastrozole as a frontline treatment for postmenopausal women with HR-positive metastatic breast cancer. These findings from the phase II FIRST trial were presented at the 2014 San Antonio Breast Cancer Symposium.

Adding bevacizumab to standard neoadjuvant chemotherapy significantly improved pathologic complete response rates in women with basal-like breast cancer compared with non-basal-like subtypes. These results from the CALGB 40603 trial were presented at the 2014 San Antonio Breast Cancer Symposium.

The PD-1 inhibitor pembrolizumab (Keytruda) has demonstrated promising clinical activity and an acceptable safety profile in heavily pretreated patients with recurrent metastatic triple-negative breast cancer (TNBC).

Patients with HIV-associated lymphoma can effectively be treated with autologous hematopoietic stem cell transplantation (AHCT), with outcomes that are similar to patients without HIV. Joseph Alvarnas, MD, presented results from a phase II study at the 2014 ASH Annual Meeting.

Anti-CD38 monoclonal antibodies continue to demonstrate promise and generate excitement that a new treatment paradigm could be on the horizon for patients with multiple myeloma.

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.