Jason M. Broderick

A supplemental biologics license application for the use of pembrolizumab as an adjuvant treatment for patients with resected, high-risk stage III melanoma has been accepted by the FDA, according to Merck, the manufacturer of the PD-1 inhibitor.

A supplemental new drug application for ibrutinib in combination with rituximab has been granted a priority review by the FDA. According to Pharmacyclics and Janssen Biotech, the codevelopers of ibrutinib, this combination could be a treatment option across all lines of therapy for patients with Waldenström macroglobulinemia.

Based on survival data from the phase III TOWER study, blinatumomab has been granted full marketing authorization by the European Commission for the treatment of adult patients with Philadelphia chromosome-negative relapsed/refractory B-cell precursor acute lymphoblastic leukemia, according to Amgen, the developer of the anti-CD19 immunotherapy.

Pembrolizumab (Keytruda) has been granted an accelerated approval by the FDA for the treatment of adult and pediatric patients with refractory primary mediastinal large B-cell lymphoma (PMBCL), or those who have relapsed after 2 or more prior lines of therapy. The approval is based on results from 53 patients with relapsed/refractory PMBCL enrolled in the multicenter, open-label, single-arm KEYNOTE‑170 trial.

Based on results from the phase III GOG-0218 trial, bevacizumab (Avastin) has been approved by the FDA for use in combination with carboplatin and paclitaxel, followed by bevacizumab monotherapy, for the treatment of women with advanced ovarian cancer following initial surgical resection.

Pembrolizumab (Keytruda) has been granted an&nbsp;accelerated approval by the FDA&nbsp;for the treatment of patients with advanced, PD-L1&ndash;positive cervical cancer with disease progression on or after chemotherapy.<br /> &nbsp;

A supplemental new drug application adding overall survival data from the phase III ASPIRE trial to the label&nbsp;for carfilzomib (Kyprolis) has been approved by the FDA, according to Amgen, the manufacturer of the proteasome inhibitor.&nbsp; Carfilzomib is approved&nbsp;for use in patients with relapsed or refractory multiple myeloma.

Based on data from the phase III MURANO trial, venetoclax has been granted a regular approval by the FDA&nbsp;for the treatment of patients with chronic lymphocytic leukemia or small lymphocytic lymphoma, with or without 17p deletion, who has received at least 1 prior therapy.

According to Pfizer, the manufacturer of the PARP inhibitor talazoparib,&nbsp;a priority review was granted by the FDA to a new drug application for this PARP inhibitor for treatment of patients with germline <em>BRCA </em>mutation&ndash;positive, HER2-negative locally advanced or metastatic breast cancer.

Results from a phase II trial demonstrated that&nbsp;cemiplimab, a PD-1 inhibitor, induced an overall response rate (ORR) of 47.5% in patients with metastatic cutaneous squamous cell carcinoma.

According to updated data from the phase I/II PIVOT-02 trial presented at the 2018 ASCO Annual Meeting, the combination of NKTR-214 plus the PD-1 inhibitor nivolumab demonstrated promising antitumor activity in patients with advanced solid tumors, particularly in PD-L1&ndash;negative patients.

According to findings of an early study presented at the 2018 ASCO Annual Meeting, the combination of pegilodecakin and a PD-1 inhibitor demonstrated an overall response rate of 41% in patients with advanced non&ndash;small cell lung cancer.&nbsp;

According to the phase III KEYNOTE-407 trial, when pembrolizumab was added to frontline carboplatin/paclitaxel or nab-paclitaxel, the combination reduced the risk of death by 36% compared with chemotherapy alone for patients with metastatic squamous non&ndash;small cell lung cancer. These results were presented at the 2018 ASCO Annual Meeting.

According to the phase III IMpower131 trial findings presented at the 2018 ASCO Annual Meeting, the risk of progression or death was reduced by 29% with the addition of atezolizumab&nbsp; to the first-line treatment regimen of carboplatin and nab-paclitaxel versus chemotherapy alone for patients with advanced squamous non&ndash;small cell lung cancer.

Risk of disease progression or death decreased by 80% with the addition of&nbsp;ibrutinib to rituximab compared with rituximab alone for patients with Waldenstr&ouml;m macroglobulinemia.

Pomalidomide in combination with bortezomib and low-dose dexamethasone demonstrated an improved median&nbsp;progression-free survival compared with&nbsp; bortezomib and low-dose dexamethasone alone in patients with&nbsp;relapsed/refractory multiple myeloma who have previously received lenalidomide, according to results from the OPTIMISMM trial.&nbsp;

A supplemental new drug application for&nbsp;eltrombopag has been granted a priority review by the FDA&nbsp;for use in combination with standard immunosuppressive therapy as a frontline treatment for patients with severe aplastic anemia, according to Novartis, the manufacturer of the oral thrombopoietin-receptor agonist.

Cabozantinib has been approved by the European Commission for previously untreated patients with&nbsp;intermediate- or poor-risk&nbsp;advanced renal cell carcinoma,&nbsp;based on a meaningful progression-free survival improvement versus sunitinib in the CABOSUN trial, according to Ipsen, which codevelops the treatment with Exelixis.

Crizotinib has been granted a breakthrough therapy designation by the FDA&nbsp;for the treatment of patients with metastatic non&ndash;small cell lung cancer with MET exon 14 alterations who progress after receiving platinum-based chemotherapy. Additionally,&nbsp;the kinase inhibitor was granted a designation for use&nbsp;patients with relapsed/refractory ALK+ anaplastic large cell lymphoma.

Based on data from the ongoing phase III ADMIRAL study, a new drug application for&nbsp;gilteritinib has been granted a priority review by the FDA for&nbsp;the treatment of adult patients with <em>FLT3</em> mutation&ndash;positive relapsed or refractory acute myeloid leukemia,&nbsp;according to Astellas Pharma, the manufacturer of the FLT3 inhibitor.

A new drug application for larotrectinib has been granted a priority review by the FDA for&nbsp;the treatment of adult and pediatric patients with locally advanced or metastatic solid tumors with an <em>NTRK</em> gene fusion, according to Bayer and Loxo Oncology, the codevelopers of the pan-TRK inhibitor.&nbsp;

According to topline results from the phase III ILLUMINATE trial, the&nbsp;combination of ibrutinib and obinutuzumab improved progression-free survival compared with chlorambucil&nbsp;plus obinutuzumab&nbsp;in patients with chronic lymphocytic leukemia or small lymphocytic lymphoma.

According to results from a posthoc analysis of the phase III SPARTAN trial, apalutamide (Erleada) lowered the risk of PSA progression by&nbsp;94% in patients with nonmetastatic castration-resistant prostate cancer.

In a cohort of pediatric and young adult patients with newly diagnosed T-cell acute lymphoblastic leukemia or T-cell lymphoblastic lymphoma, adding nelarabine to escalating-dose methotrexate (C-MTX) induced a 4-year disease-free survival rate of 91%, according to findings released ahead of the 2018 ASCO Annual Meeting.

According to top-line results from the QUADRA study, niraparib met the primary endpoint of overall response as a fourth-line or later treatment in patients with ovarian cancer, regardless of <em>BRCA</em> status.

Olaparib tablets have been approved been the European Commission as a maintenance therapy for&nbsp;patients with platinum-sensitive relapsed high-grade, epithelial ovarian, fallopian tube or primary peritoneal cancer, who are in a complete or partial response to platinum-based chemotherapy, regardless of&nbsp;<em>BRCA</em>&nbsp;status.

According to topline findings from the phase III IMblaze370 study, treatment with the combination of the PD-L1 inhibitor atezolizumab and the MEK inhibitor cobimetinib failed to improve overall survival versus regorafenib in patients with locally advanced or metastatic colorectal cancer&nbsp; who were previously treated.

According to findings from the phase III QuANTUM-R study, overall survival was improved with quizartinib compared with chemotherapy in patients with&nbsp;<em>FLT3</em>-ITD&ndash;positive relapsed/refractory acute myeloid leukemia after first-line treatment with or without hematopoietic stem cell transplantation.<br /> &nbsp;

Based on findings from the phase III IMpower150 trial, a supplemental biologics license application for atezolizumab has been granted a priority review by the FDA&nbsp;for use in combination with bevacizumab, carboplatin, and paclitaxel for the first-line treatment of patients with metastatic nonsquamous non&ndash;small cell lung cancer.

The FDA has received a supplemental biologics license application seeking approval for pembrolizumab in combination with standard chemotherapy as a treatment for patients with metastatic squamous non&ndash;small cell lung cancer.