Silas Inman


LOXO-292 Granted Breakthrough Therapy Designation for Lung and Thyroid Cancer

September 05, 2018

The FDA has granted LOXO-292 a breakthrough therapy designation for the treatment of patients with RET fusion–positive non–small cell lung cancer (NSCLC) or RET-mutant medullary thyroid cancer (MTC). This designation will expedite the development and review of the drug.

FDA Updates Immunotherapy Labels for Bladder Cancer Treatment

June 21, 2018

The FDA has incorporated PD-L1 status into the labels for Keytruda (pembrolizumab) and Tecentriq (atezolizumab) for existing frontline approvals for platinum-ineligible patients with urothelial carcinoma, based on lower overall survival (OS) rates with the PD-1/PD-L1 inhibitors compared with platinum-based chemotherapy for patients with PD-L1–low expressing platinum-eligible urothelial carcinoma.

FDA Approves Combination Treatment for Metastatic Prostate Cancer

May 24, 2018

The Food and Drug Administration (FDA) approved a new formulation of Yonsa (abiraterone acetate) in combination with methylprednisolone as a treatment for men with metastatic castration-resistant prostate cancer (mCRPC), according to Sun Pharma, the company commercializing the treatment.

FDA Approves Drug for Chronic Immune Thrombocytopenia

April 18, 2018

Tavalisse (fostamatinib) was granted approval by the Food and Drug Administration (FDA) for patients with chronic immune thrombocytopenia (ITP) after they had an insufficiencent response to another therapy.

Chemo Regimen Helps Control Locally Advanced Pancreatic Cancer

March 23, 2018

“Disease control is key in our patients with locally advanced disease, as it may lead to opportunities for additional treatment interventions, including radiotherapy, or even, in some favorable cases, surgical resection,” said lead study author Pascal Hammel, M.D., Ph.D.

Ivosidenib Granted FDA Priority Review for AML Treatment

February 15, 2018

Ivosidenib (AG-120) was granted a priority review designation by the Food and Drug Administration (FDA) for the treatment of patients with relapsed/refractory IDH1-mutant acute myeloid leukemia (AML), according to a statement from Agios Pharmaceuticals, the company developing the targeted therapy.

Gilotrif's Approval Expanded to Some Patients With Metastatic NSCLC

January 15, 2018

The Food and Drug Administration (FDA) expanded the approved use for Gilotrif (afatinib). The drug can now be used to treat patients with metastatic non-small cell lung cancer (NSCLC) who have uncommon EGFR alterations in L861Q, G719X and/or S768I.

FDA Grants Priority Review for Rare Neuroendocrine Tumor Treatment

January 02, 2018

The Food and Drug Administration (FDA) granted a priority review designation to a novel version of Azedra (iobenguane I-131), a radiopharmaceutical, to treat patients with malignant or recurrent pheochromocytoma or paraganglioma (PPGL).

Four-Drug Combination Improves NSCLC Outcomes

December 24, 2017

A four-drug combination, including Tecentriq (atezolizumab), Avastin (bevacizumab), carboplatin and paclitaxel, delayed progression or death by 38 percent in patients with advanced non-squamous non–small cell lung cancer (NSCLC), compared to those who were treated with Avastin alone.

FDA Approves New Breast Cancer Radiotherapy

December 22, 2017

The FDA has approved a novel breast-specific stereotactic body radiotherapy (SBRT) device known as GammaPod as a treatment for patients with breast cancer, based on findings from a 17-patient study.

Perjeta Combination Granted FDA Approval for Breast Cancer

December 21, 2017

The FDA has approved Perjeta (pertuzumab) in combination with Herceptin (trastuzumab) and chemotherapy as an adjuvant treatment for patients with HER2-positive early breast cancer at high risk for recurrence, based on findings from the APHINITY trial.

FDA Approves Adjuvant Opdivo for Melanoma Treatment

December 21, 2017

The FDA has approved Opdivo (nivolumab) as an adjuvant treatment for patients with completely resected melanoma with lymph node involvement or metastatic disease, based on findings from the phase 3 CheckMate-238 trial.

Bosulif Approved for Chronic Myeloid Leukemia

December 20, 2017

The FDA has approved Bosulif (bosutinib) as a first-line treatment for patients with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML), based on findings from the phase 3 BFORE trial.

Prevymis Approved to Prevent Virus in Patients Receiving Stem Cell Transplants

November 09, 2017

Prevyis (letermovir) was granted approval by the Food and Drug Administration (FDA) to prevent cytomegalovirus (CMV) infection in adult CMV-seropositive patients treated with an allogeneic hematopoietic stem cell transplant (HSCT). The result is based on a significant reduction in CMV infection rates in a phase 3 study.

FDA Approves Calquence for Mantle Cell Lymphoma

October 31, 2017

Calquence (acalabrutinib) was granted an accelerated approval by the FDA to treat adult patients with mantle cell lymphoma (MCL) following at least one prior therapy. The approval was based on objective response rates (ORR) in a single-arm trial.