Pharmaceutical Technology

NOVEMBER 25, 2022

The treatment is indicated for usage in such patients following previous chemotherapy, comprising trastuzumab and a taxane. Nausea, fatigue, vomiting, reduced neutrophil count, alopecia and anaemia among others were observed to be the most prevalent adverse reactions.

Adverse Reactions 105

Adverse Reactions Chemotherapy Labelling 105

pharmaphorum

APRIL 1, 2021

The FDA has approved Sanofi’s Sarclisa (isatuximab) in combination with a new chemotherapy regimen for advanced multiple myeloma, building on a first approval last year. In the trial, 8% of patients dropped out because of adverse events and 2.8% quit because of an infection.

Adverse Reactions 59

Adverse Reactions Labelling Chemotherapy 59

pharmaphorum

OCTOBER 19, 2020

The FDA’s approval covers use of Venclexta (venetoclax) in combination with azacytidine, or decitabine, or low-dose cytarabine (LDAC) for newly diagnosed AML in adults 75 years or older, or who have comorbidities preventing intensive induction chemotherapy. months compared with 4.1 months for those treated with LDAC alone.

Adverse Reactions 59

Adverse Reactions Chemotherapy Labelling 59

Pharmaceutical Technology

NOVEMBER 23, 2022

Libtayo is also indicated for treating progression of the disease on or following platinum-based chemotherapy. Based on the open-label, multicentre, international Phase III EMPOWER-Cervical 1 clinical trial findings, the regulatory agency granted approval in advanced cervical cancer.

Adverse Reactions 52

Adverse Reactions Chemotherapy Immunity Immunization 52

Pharmaceutical Technology

FEBRUARY 5, 2023

The FDA approval is based on the data obtained from a global, multicentre, open-label Phase III TROPiCS-02 study conducted in 543 HR+/HER2- metastatic breast cancer patients who have received prior endocrine therapy, CDK4/6 inhibitor and two to four lines of chemotherapy for metastatic disease. Trodelvy showed 3.2 Trodelvy showed 3.2

Adverse Reactions 105

Adverse Reactions Chemotherapy Labelling 105

LifeProNow

APRIL 19, 2023

The product is intended for use in adults and pediatric patients 12 years and older with blood cancers planned for umbilical cord blood transplantation following a myeloablative conditioning regimen (treatment such as radiation or chemotherapy). director of the FDA’s Center for Biologics Evaluation and Research.

Adverse Reactions 130

Adverse Reactions Chemotherapy Labelling Immunity 130

Pharmaceutical Technology

MARCH 23, 2023

The approval from the FDA was based on the data obtained from the multiregional, open-label, single-arm POD1UM-201 trial, conducted in metastatic or recurrent locally-advanced MCC adults who did not receive systemic therapy previously for their advanced disease. Partial response was seen in 22 patients and complete response in 12 patients.

Adverse Reactions 98

Adverse Reactions Compounding Chemotherapy Labelling 98