Targeted Oncology Staff

Articles by Targeted Oncology Staff

Alpelisib Receives FDA Approval in Breast Cancer

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Based on data from the phase III SOLAR-1 trial, alpelisib (Piqray) has been approved by the FDA for the treatment of postmenopausal women, and men, with HR-positive, HER2-negative, PIK3CA-mutated, advanced or metastatic breast cancer following progression on or after an endocrine-based regimen.

Erdafitinib Granted FDA Approval in Bladder Cancer

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Erdafitinib (Balversa) has been granted an accelerated approval by the FDA as a treatment for&nbsp;adult patients with locally advanced or metastatic bladder cancer with an <em>FGFR3</em> or <em>FGFR2</em> alteration that has progressed on platinum-containing chemotherapy, making it the first targeted agent to receive approval for&nbsp;metastatic bladder cancer.

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.

Darolutamide Submitted for FDA Approval in Nonmetastatic CRPC

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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.

Romiplostim Receives FDA Approval for Pediatric ITP

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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.

PFS Improved With Tivozanib in Highly Refractory RCC

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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.

TAS-102 Granted Priority Review by FDA for Gastric/GEJ Cancer

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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.