Targeted Oncology Staff

The clinical practice guidelines for the treatment of patients with colorectal cancer have been updated by NCCN to include the combination of&nbsp;encorafenib plus binimetinib in addition to EGFR inhibition with either cetuximab or panitumumab as a Category 2a treatment recommendation for patients with <em>BRAF</em> V600E&ndash;mutant metastatic CRC, after 1 or 2 prior therapies for metastatic disease.

Based on findings from the phase III ARAMIS trial, a new drug application for darolutamide has been submitted to the FDA seeking the&nbsp;investigational agent&#39;s approval as a treatment for&nbsp;patients with nonmetastatic castration-resistant prostate cancer, according to&nbsp;the codevelopers of the investigational agent, Bayer and Orion Corporation.<br /> &nbsp;

AstraZeneca and Merck, the codevelopers of olaparib, have announced that findings from the phase III POLO trial showed use of the PARP inhibitor as a frontline maintenance for patients with germline <em>BRCA</em>-mutated metastatic adenocarcinoma of the pancreas&nbsp;significantly reduced the risk of disease progression or death versus placebo.

According to findings from the phase III COLUMBA trial in patients with relapsed/refractory multiple myeloma, a&nbsp;subcutaneous formulation of daratumumab &nbsp;is noninferior in terms of inefficacy and pharmacokinetics to the standard&nbsp;intravenous daratumumab.

At a planned interim analysis of the&nbsp;phase III JAVELIN Ovarian 100 study evaluating frontline avelumab in ovarian cancer, an independent panel determined the study would not meet its primary endpoint of progression-free survival. The co-developers of the PD-L1 inhibitor have announced they will terminate the trial on this basis.

Romiplostim has been granted FDA approval for the treatment of pediatric patients aged&nbsp;&ge;1 year with immune thrombocytopenia for at least 6 months who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy.

Venetoclax (Venclexta) has been granted an accelerated approval by the FDA for combined use with&nbsp;azacitidine or decitabine or low-dose cytarabine as a treatment for&nbsp;adult patients with newly-diagnosed acute myeloid leukemia who are aged 75 years or older,&nbsp;or who have comorbidities that preclude use of intensive induction chemotherapy.

According to topline findings from the phase III TIVO-3 trial,&nbsp;tivozanib (Fotivda) reduced the risk of disease progression or death by 26% compared with sorafenib (Nexavar) in patients with highly refractory advanced or metastatic renal cell carcinoma.

Treatment-na&iuml;ve patients with chronic lymphocytic leukemia who had comorbidities saw a reduction in the risk of disease progression or death after treatment with venetoclax combined with obinutuzumab versus obinutuzumab plus chlorambucil.

Based on data from the&nbsp;phase III TAGS trial,&nbsp;a supplemental new drug application seeking approval for TAS-102&nbsp;(trifluridine/tipiracil; Lonsurf)&nbsp;for use in previously treated patients with advanced or metastatic gastric adenocarcinoma,&nbsp;including cancer of the gastroesophageal junction, has been granted a priority review by the FDA.

Patients with advanced or metastatic renal cell carcinoma who were treated with the combination of&nbsp;pembrolizumab (Keytruda) and&nbsp;axitinib (Inlyta) demonstrated a significantly improved survival benefit compared with&nbsp;sunitinib (Sutent)&nbsp;in the first-line setting, meeting the endpoints of the pivotal phase III KEYNOTE-426 trial.

Gardasil 9 (HPV 9-valent Vaccine, Recombinant), a vaccine for the prevention of HPV, has been approved by the FDA for use in males and females aged 9 through 45 years.

A new drug application for selinexor has been granted a priority review by the FDA as a treatment for patients with penta-refractory multiple myeloma, according to Karyopharm Therapeutics, the manufacturer of the agent.

ASCO has revealed its first clinical trial, which will provide patients with limited options an opportunity to receive a potentially beneficial targeted therapy that matches their distinct genetic make-up and is FDA-approved for another type of cancer.