Osimertinib (Tagrisso) has been approved by The European Commission as a frontline treatment for patients with <em>EGFR</em>-mutant locally-advanced or metastatic non–small cell lung cancer. The approval is based on data from the phase III FLAURA trial.
Overall survival improved with the combination of atezolizumab, bevacizumab, carboplatin, and paclitaxel versus a treatment regimen of bevacizumab and chemotherapy alone in patients with advanced wild-type nonsquamous non–small cell lung cancer.
Durable complete remissions were seen in 46% of patients with high-risk diffuse large B-cell lymphoma treated with the CAR T-cell therapy lisocabtagene maraleucel at 6 months. These results come from the updated findings from the phase I, multicenter TRANSCEND trial that were presented at the 2018 ASCO Annual Meeting.
Based on data reported at the 2018 ASCO Annual Meeting, the primary endpoint of the phase III RELEVANCE trial was not met with the combination of rituximab plus lenalidomide showing similar efficacy results compared with rituximab plus chemotherapy in treatment-naive patients with follicular lymphoma. The chemotherapy-free regimen, however, did show a more favorable toxicity profile.
Treatment-naive patients with chronic lymphocytic leukemia achieved high rates of minimal residual disease–negative status of 77% with peripheral blood testing after 6 cycles from treatment with ibrutinib (Imbruvica) and venetoclax (Venclexta). Additionally, patients in the CAPTIVATE trial, wihch was presented during the 2018 ASCO Annual Meeting, achieved an objective response rate of 100%.
Patients with relapsed/refractory t(11;14) multiple myeloma achieved high rates of responses when venetoclax was added to the combination of carfilzomib and dexamethasone, according to findings from an ongoing phase II study presented during the 2018 ASCO Annual Meeting.
The highly-selective RET inhibitor LOXO-292 induced an objective response rate of 77% for patients with RET fusion-positive non–small cell lung cancer, according to findings from the phase I LIBRETTO-001 study presented at the 2018 ASCO Annual Meeting.
In updated findings from the multicenter phase I CRB-401 study that were presented at the 2018 ASCO Annual Meeting, the anti-BCMA CAR T-cell therapy bb2121 induced a median progression-free survival of 11.8 months and a median duration of response of 10.8 months for patients with relapsed/refractory heavily pretreated multiple myeloma.
The review period for lenvatinib as a first-line treatment for patients with unresectable hepatocellular carcinoma has been extended by the FDA. According to Eisai and Merck, the companies codeveloping the drug, this will allow ample time to review the application.
A supplemental new drug application seeking the approval of cabozantinib for the treatment of patients with previously-treated advanced hepatocellular carcinoma has been accepted by the FDA, according to a statement from Exelixis, the company developing the agent.
Following a planned interim analysis, 2 early-phase clinical trials exploring daratumumab in combination with either a PD-1 inhibitor for multiple myeloma or a PD-L1 inhibitor for non–small cell lung cancer have been terminated, according to a statement from Genmab, the company codeveloping daratumumab with Janssen.
A new formulation of abiraterone acetate in combination with methylprednisolone has been approved by the FDA as a treatment for men with metastatic castration-resistant prostate cancer, according to Sun Pharma, the company commercializing the treatment.
A drug safety notification warning has been issued by the FDA against the use of the single-agent immune checkpoint inhibitors in the first-line setting for patients with PD-L1–low expressing platinum-eligible urothelial carcinoma. This follows findings of a decrease in overall survival with pembrolizumab and atezolizumab versus a platinum-based chemotherapy.
In patients with HER2-positive early breast cancer, 6 months of adjuvant treatment with trastuzumab (Herceptin) was noninferior for disease-free survival compared with the standard 12-month schedule, according to findings from the phase III PERSEPHONE trial presented ahead of the 2018 ASCO Annual Meeting.
According to additional analyses from the phase III RESORCE trial published in the<em> Journal of Hepatology, s</em>econd-line regorafenib continued to show antitumor activity regardless of prior dose or time to progression on frontline sorafenib (Nexavar) for patients with unresectable advanced hepatocellular carcinoma.
Daratumumab (Darzalex) in combination with bortezomib (Velcade), melphalan, and prednisone received FDA approval as a frontline regimen for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant.
Patients with metastatic or recurrent squamous cell carcinoma of the head and neck experienced a 32% reduction in the risk of death compared with investigator's choice of therapy, according to updated findings with a minimum of 2 years of follow-up from the phase III CheckMate-141 study.
After findings from 2 randomized trials and an open-label extenstion study were released, fostamatinib (Tavalisse), anSYK inhibitor, was approved by the FDA as a second-line treatment following insufficient response to a previous therapy for patients with chronic immune thrombocytopenia.
In a precision medicine success story, crizotinib (Xalkori) demonstrated a 50% objective response rate and a 100% disease control rate in patients with <em>ALK</em>-positive advanced, inoperable inflammatory tumors, in findings from the CREATE study presented at the 2018 AACR Annual Meeting.
Abemaciclib, the only CDK4/6 inhibitor approved as a single-agent, has amassed several clinical indications for patients with metastatic breast cancer. The findings from the phase III MONARCH2 and 3 trials, as well as the phase II MONARCH1 study led to these approvals. Each trial showed improvements in progression-free survival, especially in patients with visceral disease and endocrine therapy resistance.
Presented at the 2018 Miami Breast Cancer Conference, results from the phase III OlympiAD trial demonstrated improvements in progression-free survival with olaparib over treatment of physician's choice. These results were consistent regardless of the baseline tumor burden for patients with HER2-negative breast cancer with a germline <em>BRCA</em>1/2 mutation.
Based on findings from a phase I trial presented at the 2017 ASH Annual Meeting, ivosidenib (AG-120) has been granted a priority review designation by the FDA for the treatment of patients with relapsed/refractory <em>IDH1</em>-mutant acute myeloid leukemia.
In findings from the phase III PROSPER trial released ahead of the 2018 Genitourinary Cancers Symposium, the enzalutamide (Xtandi) and androgen deprivation therapy (ADT) combination reduced the risk of metastases or death by 71% compared with ADT alone for the treatment of patients with nonmetastatic castration-resistant prostate cancer (CRPC).
As stated in findings from IMmotion151, a phase III open-label study, the combination of atezolizumab (Tecentriq) and bevacizumab (Avastin) induced a 26% reduction in the risk of progression or death compared with sunitinib (Sutent) for patients with untreated PD-L1–positive metastatic renal cell carcinoma. This study was released ahead of the 2018 Genitourinary Cancers Symposium.
The combination of abiraterone acetate in combination with prednisone and androgen deprivation therapy has been approved by the FDA as a treatment for men with high-risk castration-sensitive prostate cancer.
According to findings from the phase III CELESTIAL trial released ahead of the 2018 Gastrointestinal Cancers Symposium, cabozantinib (Cabometyx) improved median overall survival by 2.2 months compared with placebo for patients with previously treated advanced hepatocellular carcinoma.
In patients with newly diagnosed locally advanced pancreatic cancer, induction treatment with nab-paclitaxel (Abraxane) plus gemcitabine induced an overall disease control rate of 77.6%, according to updated findings from the phase II LAPACT trial presented at the 2018 Gastrointestinal Cancers Symposium.
Based on findings from the ALCYONE study, which were published in the <em>New England Journal of Medicine</em> and presented at the 2017 ASH Annual Meeting,<sup> </sup>the FDA has granted a priority review designation to daratumumab (Darzalex) in combination with bortezomib (Velcade), melphalan, and prednisone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant.
Arsenic trioxide (Trisenox) has been approved by the FDA in combination with the all-trans retinoic acid agent tretinoin for the treatment of adults with newly-diagnosed low-risk acute promyelocytic leukemia with the t(15;17) translocation or <em>PML-RARA</em> gene expression.
The frontline indication for afatinib (Gilotrif) has been expanded by the FDA to include the treatment of patients with metastatic non–small cell lung cancer whose tumors harbor uncommon <em>EGFR</em> alterations in L861Q, G719X, and/or S768I.