Silas Inman

Axicabtagene ciloleucel (axi-cel) elicited a 2-year overall survival (OS) rate of 51% in patients with refractory large B cell lymphoma, representing a clear plateau in the survival curve.

The anti-BCMA CAR T-cell therapy bb21217 demonstrated an objective response rate of 83.3%, with a very good partial response or better rate of 75% in patients with heavily pretreated relapsed/refractory multiple myeloma, according to initial results from a phase I study presented at the 2018 ASH Annual Meeting.

The FDA has approved the CD22-directed recombinant immunotoxin moxetumomab pasudotox (Lumoxiti) for the treatment of adult patients with relapsed or refractory hairy cell leukemia (HCL) who have received at least 2 prior lines of therapy, including treatment with a purine nucleoside analog.

The FDA granted breakthrough therapy designation to the oral agent LOXO-292 for the treatment of RET fusion–positive non–small cell lung cancer (NSCLC) or RET-mutant medullary thyroid cancer (MTC).

Patients with relapsed/refractory heavily pretreated multiple myeloma could live for an extra progression-free year with the use of the anti-BCMA CAR T-cell therapy bb2121.

A promising CD19-directed chimeric antigen (CAR) T-cell therapy, Lisocabtagene maraleucel (JCAR017; liso-cel), may result in durable remissions among patients with high-risk diffuse large B-cell lymphoma (DLBCL), the most common type of non-Hodgkin lymphoma.

Patients with relapsed/refractory heavily pretreated multiple myeloma could live for an extra progression-free year with the use of the anti-BCMA CAR T-cell therapy bb2121.

The FDA has approved a new formulation of abiraterone acetate (Yonsa) to be used in combination with methylprednisolone to treat metastatic castration-resistant prostate cancer (mCRPC).

The FDA has approved the monoclonal antibody daratumumab (Darzalex), in combination with bortezomib (Velcade), melphalan, and prednisone (VMP) for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant.

The FDA approved fostamatinib disodium hexahydrate (Tavalisse), an SYK inhibitor, as a second-line treatment for patients with chronic immune thrombocytopenia following insufficient response to a previous therapy.

The availability of PARP inhibitors for the treatment of patients with BRCA-mutant metastatic breast cancer has the potential to usher in a new era for targeted therapies.

Agios Pharmaceuticals announced that the FDA has granted a priority review designation to its targeted therapy, ivosidenib (AG-120), for the treatment of patients with relapsed/refractory IDH1-mutant acute myeloid leukemia (AML).

Based on findings from the phase III LATITUDE trial, the Food and Drug Adminstration has approved abiraterone acetate (Zytiga) for use in high-risk patients with castration-sensitive prostate cancer.

Daratumumab (Darzalex) in combination with bortezomib (Velcade), melphalan, and prednisone (VMP), has been granted a priority review designation by the FDA for patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant.

Approval opens up treatment possibilities for lung cancer patients with rare genetic mutations.

Progenics Pharmaceuticals announced that the FDA has granted a priority review designation to a novel version of the radiopharmaceutical iobenguane I-131 (Azedra), for patients with malignant or recurrent pheochromocytoma or paraganglioma.

The combination of olaparib (Lynparza) and durvalumab (Imfinzi) for pretreated patients with germline BRCA-mutated (gBRCAm), HER2-negative metastatic breast cancer shows great promise for future treatment.

The FDA has approved a novel breast-specific stereotactic body radiotherapy (SBRT) device known as GammaPod as a treatment for patients with early breast cancer, based on findings from a 17-patient study.

The FDA has approved the combination of pertuzumab (Perjeta), trastuzumab (Herceptin) and chemotherapy as an adjuvant treatment for patients with HER2-positive early breast cancer at high risk for recurrence.

Nivolumab (Opdivo) is now approved by the Food and Drug Administration (FDA) as an adjuvant treatment for patients with completely resected melanoma with lymph node involvement or metastatic disease.

Based on findings from the phase III BFORE trial, the FDA has approved Bosutinib as a first-line treatment for a chronic myeloid leukemia subtype.

The FDA approved abozantinib (Cabometyx) for use in previously untreated patients who have advanced renal cell carcinoma (RCC).

The FDA has approved letermovir (Prevymis) to prevent cytomegalovirus (CMV) infection in adult CMV-seropositive patients treated with an allogeneic hematopoietic stem cell transplant (HSCT), based on a significant reduction in CMV infection rates in a phase III study.

The FDA has granted an accelerated approval to acalabrutinib (Calquence) as a treatment for adult patients with mantle cell lymphoma (MCL) following at least 1 prior therapy, based on objective response rates (ORR) in a single-arm trial.

The FDA has approved axicabtagene ciloleucel (axi-cel; Yescarta) as a treatment for adults with relapsed or refractory non-Hodgkin lymphoma (NHL). This CAR T-cell therapy breaks new ground in treatment for the disease.

"This is a clear improvement in the outcome, with increased PFS—by about 11 months—consistent improvement in response rate, and decreases in the development of metastatic disease," said lead investigator Luis Paz-Ares, MD, chair, Medical Oncology Department, Hospital Universitario Doce de Octubre.

The FDA has approved CPX-351 (Vyxeos), a fixed-combination of daunorubicin and cytarabine, for adult patients with either newly-diagnosed therapy-related acute myeloid leukemia (t-AML) ot AML with myelodysplasia-related changes (AML-MRC).

The FDA has approved enasidenib for patients with IDH2-Mutated acute myeloid leukemia (AML).

Checkpoint inhibitors against PD-1 and PD-L1 have shown promise, both as monotherapies and in combination with chemotherapy for patients with triple-negative breast cancer (TNBC).

The FDA has approved ClearLLab multicolor reagents for the detection of chronic leukemia, acute leukemia, non-Hodgkin lymphoma, multiple myeloma, myelodysplastic syndrome and myeloproliferative neoplasms.