Following a recommendation from the Oncologic Drugs Advisory Committee against the accelerated approval of selinexor for the treatment of patients with penta-refractory multiple myeloma, the FDA has added 3 months to the review period for the new drug application, making the new action date July 6, 2019.
In an 8 to 5 vote, the FDA's Oncologic Drugs Advisory Committee decided against the accelerated approval of a new drug application for selinexor for the treatment of patients with penta-refractory multiple myeloma. Instead, the committee recommended delaying a decision on the NDA until results are available from the pivotal phase III BOSTON trial.
Based on data from the phase III AUGMENT trial, a supplemental new drug application for the R<sup>2</sup> regimen of lenalidomide plus rituximab has been granted a priority review designation by the FDA as a therapy for patients with previously treated follicular lymphoma and marginal zone lymphoma.
Based on data from the phase III TAGS trial, TAS-102 has been approved by the FDA as a treatment for adult patients with metastatic gastric or gastroesophageal junction adenocarcinoma previously treated with at least 2 prior lines of chemotherapy that included a fluoropyrimidine, a platinum, either a taxane or irinotecan, and if appropriate, HER2/neu-targeted therapy.
A supplemental new drug application for ivosidenib has been granted a priority review designation by the FDA for the frontline treatment of patients <em>IDH1</em>-mutant acute myeloid leukemia who are ineligible for standard chemotherapy, according to Agios, the manufacturer of ivosidenib.
Polatuzumab vedotin, an antibody-drug conjugate that has demonstrated a 40% complete response rate in patients with relapsed/refractory diffuse large B-cell lymphoma, has been granted a priority review designation by the FDA in combination with bendamustine and rituximab for the treatment of these patients, according to Genentech, the manufacturer of the agent.
In updated 30-month follow-up data from the phase III CheckMate-214 trial, nivolumab combined with low-dose ipilimumab sustained strong responses and a survival benefit as a frontline treatment for patients with intermediate- and poor-risk advanced renal cell carcinoma.
Treatment with the novel targeted radiation therapy lutetium-177 PSMA-617 demonstrated strong clinical activity and the potential to improve survival in heavily pretreated men with PSMA-positive metastatic castration-resistant prostate cancer, according to phase II findings to be presented at the 2019 Genitourinary Cancers Symposium.
The review period for a supplemental new drug application for ruxolitinib has been extended by the FDA by 3 months, making the new action date May 24, 2019. The application is seeking the approval of the JAK1/JAK2 inhibitor as a treatment for patients with acute graft-versus-host disease who have had an inadequate response to corticosteroids.<br />
A supplemental Biologics License Application for ado-trastuzumab emtansine (T-DM1; Kadcyla) has been submitted to the FDA seeking approval for the agent as an adjuvant treatment for patients with HER2-positive early breast cancer who had residual disease following neoadjuvant therapy.
FDA approval is being sought for the combination of daratumumab with lenalidomide and dexamethasone for the treatment of newly diagnosed patients with multiple myeloma who are not candidates for high-dose chemotherapy and autologous stem-cell transplant. Genmab, which co-develops daratumumab with Janssen Biotech, announced that a supplemental Biologics License Application has been initiated with the FDA.
Cabozantinib has been approved by the FDA for the treatment of patients with hepatocellular carcinoma who previously received sorafenib, Exelixis, the company developing the agent, announced today.
The review period for a supplemental biologics license application for first-line treatment with pembrolizumab monotherapy for the treatment of patients with locally advanced or metastatic nonsquamous or squamous non–small cell lung cancer with PD-L1 expression (tumor proportion score) of ≥1% and no <em>EGFR </em>or <em>ALK </em>genomic tumor aberrations has been extended by the FDA, according to a press release by Merck, the manufacturer of pembrolizumab.
The use of brentuximab vedotin in combination with chemotherapy has been recommended for approval by the European Medicines Agency’s Committee for Medicinal Products for Human Use as a frontline treatment for adult patients with CD30+ stage IV Hodgkin lymphoma.
AstraZeneca has reported that the phase III EAGLE trial has missed its primary endpoint, as patients with recurrent or metastatic head and neck squamous cell carcinoma who progressed after platinum-based chemotherapy did not see a survival benefit with durvalumab alone or combined with tremelimumab.
Findings from the phase III KATHERINE study showed adjuvant treatment with ado-trastuzumab emtansine (T-DM1; Kadcyla) reduced the risk of invasive disease recurrence or death by 50% compared with trastuzumab (Herceptin) in patients with HER2-positive early breast cancer who had residual invasive disease following neoadjuvant therapy.
Based on findings from the phase III IMpower133 study, a supplemental biologics license application (sBLA) for atezolizumab (Tecentriq) has been granted a priority review by the FDA for use in combination with carboplatin and etoposide for the frontline treatment of patients with extensive-stage small cell lung cancer.
According to the phase III MAIA trial, triplet regimen daratumumab, lenalidomide, plus dexamethasone reduced risk of disease progression or death by 44% in newly diagnosed patients with multiple myeloma who were not candidates for high-dose chemotherapy and autologous stem-cell transplant, compared to patients who received lenalidomide plus dexamethasone.
An update on the pivotal phase III QuANTUM-R study presented at the 2018 ASH Annual Meeting demonstrated overall survival benefit across patient subgroups with quizartinib in patients with relapsed/refractory <em>FLT3</em>-ITD–mutated acute myeloid leukemia.
Lenalidomide in addition to rituximab, called the R<sup>2</sup> regimen, led to a significant increase in progression-free survival compared with rituximab alone in patients with relapsed/refractory indolent non-Hodgkin lymphoma in results from the phase III AUGMENT trial.
Pembrolizumab in combination with umbralisib and ublituximab induced responses in 90% of patients with relapsed/refractory chronic lymphocytic leukemia, according to data from a phase I/II study presented at the 2018 ASH Annual Meeting. Additionally, a 50% response rate was also demonstrated in patients with Richter’s transformation.
According to findings from the FLYER trial presented at the 2018 ASH Annual Meeting, treatment with 2 fewer frontline cycles of R-CHOP greatly reduced toxicity in younger patients with low-risk diffuse large B-cell lymphoma. The progression-free survival rates were also similar between the 2 arms.
Progression-free survival was significantly improved with both ibrutinib as monotherapy and in combination with rituximab when compared to bendamustine plus rituximab as a treatment for older patients with newly diagnosed chronic lymphocytic leukemia. These data were presented at the 2018 ASH Annual Meeting.
The FDA has granted an accelerated approval to larotrectinib (Vitrakvi) for use in adult and pediatric patients with solid tumors that have an <em>NTRK</em> gene fusion without a known acquired resistance mutation, are metastatic or where surgical resection is likely to result in severe morbidity, and have no satisfactory alternative treatments or that have progressed following treatment.
A new drug application for quizartinib has been granted a priority review by the FDA for the treatment of adult patients with relapsed/refractory <em>FLT3</em>-ITD–positive acute myeloid leukemia. The designation is based on findings from the phase III QuANTUM-R study.
Blinatumomab has received support from the European Medicines Agency’s Committee for Medicinal Products for Human Use. The agent has been recommended for approval as a treatment of adult patients with B-cell precursor acute lymphoblastic leukemia who are in remission but still have minimal residual disease of at least 0.1%.
Using durvalumab (Imfinzi) combined with tremelimumab for the frontline treatment of patients with metastatic non–small cell lung cancer did not result in a statistically significant improvement in overall survival compared to standard chemotherapy, according to a press release from AstraZeneca.
Brentuximab vedotin (Adcetris) has been granted FDA approval for use in combination with chemotherapy for the frontline treatment of patients with CD30-expressing peripheral T-cell lymphoma, based on findings from the phase III ECHELON-2 trial.
A supplemental biologics license application for the frontline combination of atezolizumab plus nab-paclitaxel has been granted a priority review by the FDA for the treatment of patients with unresectable locally advanced or metastatic PD-L1–positive triple-negative breast cancer, based on data from the phase III IMpassion130 trial.
Based on data from the phase III SOLO-1 trial, a supplemental new drug application for olaparib tablets has been granted a priority review by the FDA for use as a maintenance therapy in patients with newly-diagnosed,<em> BRCA</em>-positive advanced ovarian cancer who achieved a complete or partial response to standard frontline platinum-based chemotherapy.