Jason M. Broderick

Adding&nbsp;bevacizumab to erlotinib significantly improved&nbsp;progression-free survival compared with erlotinib&nbsp;alone in patients with <em>EGFR</em>-positive, advanced nonsquamous non&ndash;small cell lung cancer, suggesting the combination may have the potential to become standard of care for this patient population.

A partial clinical hold has been placed on&nbsp;all clinical trials examining venetoclax in multiple myeloma,&nbsp;according to AbbVie, co-developer of the BCL-2 inhibitor with Genentech. This hold, placed by the FDA,&nbsp;halts enrollment of new patients on the studies.

Following a recommendation from the&nbsp;Oncologic Drugs Advisory Committee against the accelerated approval of&nbsp;selinexor for the treatment of patients with penta-refractory multiple myeloma, the FDA has added&nbsp;3 months to the review period for the new drug application,&nbsp;making the new action date July 6, 2019.

In an 8 to 5 vote, the FDA&#39;s&nbsp;Oncologic Drugs Advisory Committee decided against the&nbsp;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&nbsp;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&nbsp;R²&nbsp;regimen of lenalidomide plus rituximab has been granted a priority review designation by the FDA&nbsp;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&nbsp;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&nbsp;for the frontline treatment of patients <em>IDH1</em>-mutant acute myeloid leukemia who are ineligible for standard chemotherapy, according to&nbsp;Agios, the manufacturer of ivosidenib.

Polatuzumab vedotin, an&nbsp;antibody-drug conjugate that has demonstrated a 40% complete response rate in patients with&nbsp;relapsed/refractory diffuse large B-cell lymphoma, has been granted a&nbsp;priority review designation by the FDA in combination with&nbsp;bendamustine and rituximab for the treatment of these patients,&nbsp;according to Genentech, the manufacturer of the agent.

In updated 30-month follow-up data from the&nbsp;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&nbsp;novel targeted radiation therapy lutetium-177 PSMA-617 demonstrated&nbsp;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&nbsp;supplemental new drug application for&nbsp;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&nbsp;JAK1/JAK2&nbsp;inhibitor as a treatment for&nbsp;patients with acute graft-versus-host disease who have had an inadequate response to corticosteroids.<br /> &nbsp;

A&nbsp;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&nbsp;daratumumab with&nbsp;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,&nbsp;which co-develops daratumumab with Janssen Biotech, announced that a&nbsp;supplemental Biologics License Application has been initiated with the FDA.

Cabozantinib has been approved by the FDA for the treatment of&nbsp;patients with hepatocellular carcinoma who previously received sorafenib, Exelixis, the company developing the agent, announced today.

The review period for&nbsp;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&ndash;small cell lung cancer with PD-L1 expression (tumor proportion score) of &ge;1% and no&nbsp;<em>EGFR&nbsp;</em>or&nbsp;<em>ALK&nbsp;</em>genomic tumor aberrations has been extended by the FDA, according to a press release by Merck,&nbsp;the manufacturer of pembrolizumab.

The use of&nbsp;brentuximab vedotin in combination with chemotherapy has been recommended for approval by the&nbsp;European Medicines Agency&rsquo;s Committee for Medicinal Products for Human Use as a frontline treatment for&nbsp;adult patients with CD30+ stage IV Hodgkin lymphoma.

AstraZeneca has reported that the&nbsp;phase III EAGLE trial has missed its primary endpoint, as patients with&nbsp;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&nbsp;tremelimumab.

Findings from the&nbsp;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&nbsp;for use in combination with carboplatin and etoposide for the frontline treatment of&nbsp;patients with extensive-stage small cell lung cancer.

According to the phase III MAIA trial, triplet regimen&nbsp;daratumumab, lenalidomide, plus dexamethasone reduced risk of disease progression or death by 44%&nbsp;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&nbsp;lenalidomide plus dexamethasone.

An update on the pivotal phase III&nbsp;QuANTUM-R study presented at the 2018 ASH Annual Meeting demonstrated overall survival benefit across patient subgroups with&nbsp;quizartinib in patients with&nbsp;relapsed/refractory <em>FLT3</em>-ITD&ndash;mutated acute myeloid leukemia.&nbsp;

Lenalidomide in addition to rituximab, called the R² regimen, led to a significant increase in progression-free survival compared with rituximab alone in patients with&nbsp;relapsed/refractory indolent non-Hodgkin lymphoma in results from the phase III AUGMENT trial.

Pembrolizumab in combination with&nbsp;umbralisib and ublituximab induced responses in 90% of patients&nbsp;with&nbsp;relapsed/refractory chronic lymphocytic leukemia, according to data from a phase I/II study presented at the&nbsp;2018 ASH Annual Meeting. Additionally, a&nbsp;50% response rate was also demonstrated in patients with&nbsp;Richter&rsquo;s transformation.

According to findings from the FLYER trial presented at the 2018 ASH Annual Meeting, treatment&nbsp;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.&nbsp;

Progression-free survival was significantly improved with both ibrutinib as monotherapy and in combination with rituximab when&nbsp;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&nbsp;accelerated approval to larotrectinib (Vitrakvi)&nbsp;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&nbsp;quizartinib has been granted a priority review by the FDA&nbsp;for the treatment of adult patients with relapsed/refractory&nbsp;<em>FLT3</em>-ITD&ndash;positive acute myeloid leukemia. The designation is based on findings from the&nbsp;phase III QuANTUM-R study.&nbsp;

Blinatumomab has received support from the European Medicines Agency&rsquo;s Committee for Medicinal Products for Human Use. The agent has been recommended for approval as a treatment of adult patients with&nbsp;B-cell precursor acute lymphoblastic leukemia who are in remission but still have minimal residual disease of at least 0.1%.

Using durvalumab&nbsp;(Imfinzi) combined with&nbsp;tremelimumab for the frontline treatment of patients with metastatic non&ndash;small cell lung cancer did not result in a&nbsp;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&nbsp;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.