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FDA grants approval to Gilead Sciences’ breast cancer therapy

Pharmaceutical Technology

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

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US FDA approves Incyte’s merkel cell carcinoma therapy

Pharmaceutical Technology

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.

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Japan’s MHLW approves Daiichi Sankyo’s breast cancer treatment

Pharmaceutical Technology

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.

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EC approves Regeneron’s immunotherapy for cervical cancer

Pharmaceutical Technology

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.

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FDA grants full approval for Roche/AbbVie’s Venclexta in AML combination therapies

pharmaphorum

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.

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Sanofi’s Sarclisa gains new US multiple myeloma indication

pharmaphorum

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.

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How many days should I give my dog metronidazole?

The Checkup by Singlecare

Technically, treating animals is an off-label use for this antibacterial and antimicrobial drug, but metronidazole works for anaerobic bacteria infections, inflammatory bowel disease, giardia, acute diarrhea , and dental infections. Certain supplements, flea medications, and chemotherapy drugs may also cause adverse reactions.

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