Jason M. Broderick

Dacomitinib has been approved by the FDA for the treatment of previously untreated patients with metastatic non&ndash;small cell lung cancer with&nbsp;<em>EGFR&nbsp;</em>exon 19 deletion or exon 21 L858R substitution mutations.

According to an announcement from Array BioPharma, the company developing the regimen, the European Commission approved the combination of encorafenib, a BRAF inhibitor, and binimetinib, a MEK inhibitor, for treatment of adult patients with&nbsp;<em>BRAF</em>&nbsp;V600&ndash;mutant unresectable or metastatic melanoma.

Minimal residual disease data from the phase III MURANO trial has been added to the label for venetoclax (Venclexta) by the FDA for its&nbsp;approved use in combination with rituximab (Rituxan) for previously-treated patients with chronic lymphocytic leukemia.

Progression-free survival was significantly improved in treatment-na&iuml;ve patients with advanced renal cell carcinoma by combining&nbsp;the PD-L1 inhibitor avelumab (Bavencio) with the VEGF inhibitor axitinib (Inlyta) compared with sunitinib, according to findings from the phase III JAVELIN Renal 101 study.

Frontline pembrolizumab (Keytruda) has been approved by the European Commission for&nbsp;use in combination with standard chemotherapy as a treatment for patients with metastatic nonsquamous non&ndash;small cell lung cancer without <em>EGFR</em>&nbsp;or <em>ALK</em> mutations. The approval is&nbsp;based on results from the phase III KEYNOTE-189 trial.

A supplemental biologics license application for pembrolizumab (Keytruda) has been granted a priority review by the FDA&nbsp;for the treatment of pediatric and adult patients with recurrent locally advanced or metastatic Merkel cell carcinoma. The application is seeking accelerated approval for the PD-1 inhibitor, manufactured by Merck.

A supplemental biologics license application for dasatinib (Sprycel) for use in combination with chemotherapy for the treatment of pediatric patients with newly diagnosed Philadelphia chromosome&ndash;positive acute lymphoblastic leukemia has been accepted by the FDA.

The combination of&nbsp;dabrafenib (Tafinlar) and trametinib (Mekinist) has gained approval from the European Commission for the adjuvant treatment of patients with&nbsp;<em>BRAF&nbsp;</em>V600&ndash;positive stage III melanoma following complete resection.

Blinatumomab (Blincyto) has been approved by the European&nbsp;Commission for the treatment of&nbsp;pediatric patients with Philadelphia chromosome&ndash;negative, CD19-positive B-cell precursor acute lymphoblastic leukemia that is refractory or in relapse after receiving at least 2 prior therapies or in relapse after receiving prior allogeneic hematopoietic stem cell transplantation

Axicabtagene ciloleucel (axi-cel; Yescarta) has been approved by the European Commission as a treatment for&nbsp;adult patients with relapsed/refractory diffuse large B-cell lymphoma or primary mediastinal large B-cell lymphoma, following at least 2 lines of systemic therapy.&nbsp;

Tisagenlecleucel has gained approval from the European Commission as a treatment for adult&nbsp;patients with diffuse large B-cell lymphoma that is relapsed or refractory after 2 or more lines of systemic therapy, or patients up to 25 years of age with B-cell acute lymphoblastic leukemia that is refractory, in relapse posttransplant, or in second or later relapse.

Based on findings from the phase III iNNOVATE trial, ibrutinib has been approved by the FDA in combination with rituximab for patients with Waldenstr&ouml;m macroglobulinemia across all lines of therapy.<br /> &nbsp;

Lenvatinib (Lenvima) has been approved by the European Commission as a first-line treatment for&nbsp;adults with advanced or unresectable hepatocellular carcinoma,&nbsp;based on data from the phase III REFLECT trial.

A supplemental biologics license application for elotuzumab<em>&nbsp;</em>has been granted a priority review by the FDA&nbsp;for use in combination with pomalidomide and low-dose dexamethasone as a treatment for patients with relapsed/refractory multiple myeloma following 2 or more prior therapies, including lenalidomide and a proteasome inhibitor.<br /> &nbsp;

Pembrolizumab has been granted a full approval by the FDA in combination with standard chemotherapy for patients with&nbsp;metastatic nonsquamous non&ndash;small cell lung cancer. The approval is based on results from the phase III KEYNOTE-189 trial.

An accelerated approval has been granted by the FDA to single-agent nivolumab for the treatment of patients with small cell lung cancer with disease progression following a platinum-based chemotherapy and 1 other prior line of therapy.

Lenvatinib (Lenvima) has been granted approval by the FDA&nbsp;as a first-line treatment for patients with unresectable hepatocellular carcinoma,&nbsp;based on data from the phase III REFLECT trial.

Karyopharm Therapeutics has announced that a rolling submission of an FDA new drug application has been completed for&nbsp;selinexor as a treatment for patients with penta-refractory multiple myeloma,&nbsp;based on results from part 2 of the phase IIb STORM trial.

Mogamulizumab-kpkc&nbsp;(Poteligeo) has been approved by the FDA as a treatment for patients with cutaneous T-cell lymphoma who have received at least 1 prior systemic therapy.

The triplet combination of&nbsp;the BRAF inhibitor encorafenib, the MEK inhibitor binimetinib, and the EGFR inhibitor cetuximab has been granted a breakthrough therapy designation by the FDA for the&nbsp;treatment of patients with <em>BRAF</em> V600E&ndash;mutant metastatic colorectal cancer following 1 or 2 prior lines of treatment in the metastatic setting.&nbsp;The designation will expedite the development and review of the novel triplet in this setting.

Lurbinectedin (PM1183) has been granted orphan drug designation from the FDA for&nbsp;the treatment of patients with small cell lung cancer, according to PharmaMar, the manufacturer of the marine-derived treatment.

The combination of&nbsp;lenvatinib (Lenvima) and pembrolizumab (Keytruda) has been granted a breakthrough therapy designation by the FDA as a treatment for patients with advanced and/or metastatic non&ndash;microsatellite instability high/proficient mismatch repair endometrial carcinoma who have progressed after &ge;1 prior systemic therapy.&nbsp;This designation will allow for the expedited development and review of the combination in this setting.

Quizartinib has been granted a breakthrough therapy designation by the FDA&nbsp;for the treatment of adult patients with relapsed/refractory&nbsp;<em>FLT3</em>-ITD&ndash;positive acute myeloid leukemia.

Adjuvant nivolumab has been approved by the European Commission as a treatment for adult patients with&nbsp;completely resected melanoma with lymph node involvement or metastatic disease, regardless of <em>BRAF</em> mutation status,&nbsp;based on findings from the randomized phase III CheckMate-238 trial.

The approval of pembrolizumab has been recommended by the&nbsp;European Medicines Agency&rsquo;s Committee for Medicinal Products for Human Use as a frontline treatment for&nbsp;patients with metastatic nonsquamous non&ndash;small cell lung cancer without <em>EGFR</em> or <em>ALK</em> mutations, regardless of PD-L1 expression. The recommendation is based on data from the&nbsp;phase III KEYNOTE-189 trial.

Iobenguane I-131 has been approved by the FDA for the treatment of&nbsp;adult and pediatric patients aged &ge;12 years with iobenguane scan&ndash;positive, unresectable, locally advanced or metastatic pheochromocytoma or paraganglioma who require systemic anticancer therapy, based on&nbsp;findings from a phase IIb clinical trial that was conducted under the FDA&#39;s special protocol assessment.

The primary endpoint of the phase III ALTA-1L trial has been met, as brigatinib was found to reduce the risk of&nbsp;disease progression or death versus crizotinib in adult patients with locally advanced or metastatic <em>ALK</em>-positive non&ndash;small cell lung cancer who had not received a prior ALK inhibitor,&nbsp;Takeda Pharmaceutical Company, the manufacturer of brigatinib, has announced.

The R² regimen of lenalidomide (Revlimid) with&nbsp;rituximab (Rituxan) significantly improved progression-free survival compared with&nbsp;rituximab monotherapy in the&nbsp;treatment of patients with relapsed/refractory indolent lymphoma, meeting the primary endpoint of the phase III AUGMENT trial, Celegene,&nbsp;the manufacturer of lenalidomide, has announced.

According to findings from the&nbsp;phase III IMpower132 study, the addition of atezolizumab to pemetrexed and cisplatin or carboplatin reduced the risk of disease progression or death compared with chemotherapy alone in patients with&nbsp;advanced nonsquamous non&ndash;small cell lung cancer.

Atezolizumab (Tecentriq) has been granted a breakthrough therapy designation by the FDA for use in combination with&nbsp;bevacizumab (Avastin) as a first-line treatment for patients with advanced or metastatic hepatocellular carcinoma.