Jason M. Broderick

The FDA has granted the PD-L1 inhibitor avelumab a breakthrough therapy designation for use in combination with the VEGF inhibitor axitinib in treatment-naïve patients with advanced renal cell carcinoma.

The FDA has granted a priority review to a new drug application for apalutamide for the treatment of patients with nonmetastatic castration-resistant prostate cancer.

The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended approval of ipilimumab for the treatment of pediatric patients aged 12 years and older with unresectable or metastatic melanoma.

The FDA has granted a priority review to a supplemental new drug application for the use of osimertinib as a first-line treatment for patients with non–small cell lung cancer whose tumors harbor EGFR mutations.

Pembrolizumab did not improve survival as a second-line treatment for PD-L1–positive patients with advanced gastric or gastroesophageal junction adenocarcinoma, according to findings from the phase III KEYNOTE-061 trial.

The FDA has granted a priority review to a sBLA for use of the combination of nivolumab and ipilimumab as a frontline treatment for intermediate- and poor-risk patients with advanced RCC.

The B-cell maturation antigen antibody-drug conjugate GSK2857916 induced an overall response rate of 60% in heavily pretreated patients with multiple myeloma.

The combination of venetoclax and rituximab reduced the risk of disease progression or death by 83% versus bendamustine plus rituximab in patients with relapsed or refractory chronic lymphocytic leukemia.

The frontline combination of atezolizumab, obinutuzumab, and bendamustine, achieved a complete response in 75% of patients with follicular lymphoma, according to findings from a phase Ib/II trial.

Cemiplimab as a monotherapy and in combination with the monoclonal antibody REGN1979 demonstrated clinical activity in patients with B-cell non-Hodgkin lymphoma and Hodgkin lymphoma.

The CAR T-cell therapy tisagenlecleucel (Kymriah) achieved an overall response rate of 53.1% in adult patients with relapsed/refractory diffuse large B-cell lymphoma.

The anti-CCR4 monoclonal antibody mogamulizumab reduced the risk of progression or death by 47% compared with vorinostat (Zolinza) in previously treated patients with cutaneous T-cell lymphoma.

Adding ramucirumab to cisplatin and capecitabine or 5-FU in the frontline setting did not improve overall survival in patients with HER2-negative metastatic gastric or gastroesophageal junction adenocarcinoma, according to topline results from the phase III RAINFALL trial.

The PARP inhibitor talazoparib reduced the risk of disease progression or death by 46% versus chemotherapy in patients with BRCA-positive advanced breast cancer.

The phase III SOLD trial failed to demonstrate that DFS with 9 weeks of adjuvant trastuzumab was noninferior to the standard 12 months when the 2 regimens were combined with chemotherapy in women with early stage HER2-positive breast cancer.

The combination of pembrolizumab and trastuzumab reached an objective response rate of 15.2% in patients with trastuzumab-resistant, PD-L1–positive, HER2-positive breast cancer.

The FDA has lifted partial clinical holds placed on the phase I CheckMate-039 and phase II CA204142 trials exploring nivolumab-based regimens in patients with relapsed/refractory multiple myeloma.

The FDA has granted a priority review to a supplemental new drug application for rucaparib (Rubraca) for use as a maintenance treatment for patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy.

The FDA has granted bevacizumab a full approval for the treatment of adult patients with glioblastoma that progressed following prior therapy.

The combination of ibrutinib (Imbruvica) plus rituximab (Rituxan) improved progression-free survival versus rituximab alone in patients with Waldenström macroglobulinemia.

The novel pan-TRK inhibitor larotrectinib (LOXO-101) achieved a 93% response rate in pediatric patients with TRK fusion–positive solid tumors.

The phase III ERA223 trial exploring radium-223 dichloride plus abiraterone acetate in patients with asymptomatic or mildly symptomatic chemotherapy-naïve metastatic castration-resistant prostate cancer has been unblinded early.

The FDA has approved the trastuzumab (Herceptin) biosimilar MYL-1401O (Ogivri; trastuzumab-dkst), which now has has approved indications for HER2-positive patients with breast or metastatic gastric or gastroesophageal junction adenocarcinoma.

Nivolumab improved survival versus docetaxel in a predominantly Chinese population of patients with pretreated advanced or metastatic non-small cell lung cancer.

The FDA has granted a priority review to a biologics license application for mogamulizumab for the treatment of patients with cutaneous T-cell lymphoma who have received at least 1 prior systemic therapy.

Avelumab did not improve overall survival compared with chemotherapy in previously treated patients with gastric or gastroesophageal junction adenocarcinoma, according to findings from the phase III JAVELIN Gastric 300 trial.

A sNDA has been submitted to Japan’s Pharmaceuticals and Medical Devices Agency for the use of osimertinib (Tagrisso) as a frontline treatment for patients with inoperable or recurrent EGFR-positive NSCLC.

A supplemental biologics license application has been submitted to the FDA for daratumumab for use in combination with bortezomib, melphalan and prednisone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplantation.

The European Commission has approved nilotinib (Tasigna) for the treatment of pediatric patients with Ph+ chronic myeloid leukemia in the chronic phase.

New results again demonstrated the benefit of frontline osimertinib in patients with EGFR-positive advanced non-small cell lung cancer and CNS metastases at baseline.