Jason M. Broderick

The FDA has broadened the approval of carfilzomib to include patients with relapsed multiple myeloma who have received at least one prior therapy.

The FDA has approved sonidegib (Odomzo) for the treatment of patients with locally advanced basal cell carcinoma that has recurred.

The phase III CheckMate-025 trial has been halted after an independent panel determined that nivolumab improved overall survival versus everolimus in patients with advanced renal cell carcinoma.

The FDA approved gefitinib for the frontline treatment of patients with metastatic, EGFR-positive non-small cell lung cancer.

Combining the CD30-directed antibody-drug conjugate brentuximab vedotin with R-CHOP yielded objective responses in 80% of patients with advanced DLBCL in a phase II trial.

Treatment with CPX-351 led to a relative improvement in induction response of over 40% compared with conventional 7+3 cytarabine/daunorubicin in patients with secondary acute myeloid leukemia.

Adding ofatumumab to fludarabine and cyclophosphamide reduced the risk of disease progression by 54% in patients with relapsed chronic lymphocytic leukemia.

Trabectedin reduced the risk of disease progression by 45% versus dacarbazine in patients with advanced soft tissue sarcoma.

The FDA has assigned a priority review designation to the PD-1 inhibitor pembrolizumab as a treatment for patients with advanced NSCLC across all histologies whose disease has progressed on or after platinum-containing chemotherapy, as well as a targeted agent in EGFR- or ALK-positive patients.

In the phase III PALOMA-3 trial, adding palbociclib to standard fulvestrant more than doubled progression-free survival in pretreated patients with HR-positive, HER2-negative breast cancer.

Frontline nivolumab as monotherapy and in combination with ipilimumab more than doubled progression-free survival versus ipilimumab alone in patients with advanced melanoma.

Adding ibrutinib to standard bendamustine and rituximab (BR) reduced the risk of disease progression by 80% compared with BR plus placebo in patients with pretreated CLL or SLL.

Nivolumab has now been shown to have an overall survival benefit versus docetaxel in both nonsquamous and squamous non–small cell lung cancer.

Adding elotuzumab to lenalidomide (Revlimid) and dexamethasone reduced the risk of disease progression by 30% in patients with relapsed/refractory multiple myeloma.

The FDA has granted a breakthrough therapy designation to the Bcl-2 inhibitor venetoclax (GDC-0199/ABT-199) for the treatment of patients with relapsed/refractory chronic lymphocytic leukemia who harbor a 17p deletion (del[17p]).

The FDA has assigned a priority review designation to the PD-1 inhibitor nivolumab as a treatment for previously untreated patients with unresectable or metastatic melanoma.

In a combined decision, members of the FDA's Oncologic Drugs Advisory Committee and Cellular, Tissue and Gene Therapies Advisory Committee voted 22-1 to recommend approval of the oncolytic immunotherapy talimogene laherparepvec (T-VEC) as a treatment for patients with advanced melanoma.

Frontline immunotherapy with nivolumab plus ipilimumab delayed disease progression by 60% compared with ipilimumab alone in patients with advanced melanoma.

Pembrolizumab had an overall response rate (ORR) of 45.2% among a cohort of patients with PD-L1-positive non–small cell lung cancer (NSCLC) and an ORR of nearly 20% in the full population in the phase I KEYNOTE-001 trial.

Nivolumab (Opdivo) improved survival versus docetaxel in patients with pretreated nonsquamous non–small cell lung cancer in the phase III CheckMate-057 trial.

The PALOMA-3 trial examining a palbociclib regimen in HR+/HER2- breast cancer was halted after an independent panel determined it met the primary endpoint of improving progression-free survival.

An sNDA for the full approval of carfilzomib (Kyprolis) as a treatment for patients with relapsed multiple myeloma has been granted a priority review by the FDA.

In the phase III BEACON trial, etirinotecan pegol missed the primary endpoint of significantly extending overall survival versus physician's choice of therapy.

Acting 3 months ahead of schedule, the FDA approved nivolumab (Odivo) for patients with squamous non-small cell lung cancer.

The reduction of breast cancer risk with 5 years of tamoxifen does not outweigh the lack of a mortality benefit, according to J. Michael Dixon, MD, OBE, who shared his view in a session at the 32nd Annual Miami Breast Cancer Conference.

Carfilzomib doubled progression-free survival versus bortezomib in patients with relapsed multiple myeloma in the phase III ENDEAVOR trial.

In a discussion at the Miami Breast Cancer Conference, Clifford A. Hudis, MD, suggested that an increased risk for developing breast cancer might be a consequence of inflammation that often accompanies obesity.

The FDA has granted a priority review to nivolumab for use in patients with previously treated, advanced, squamous non–small cell lung cancer.

Tumor genome profiling identifies driver mutations in breast tumors, however, it is still too early to use this information in clinical decision making.

The FDA has accepted an NDA for the oral nucleoside TAS-102 as a treatment for patients with refractory metastatic colorectal cancer.