Talzenna (Page 2 of 6)

6 ADVERSE REACTIONS

The following clinically significant adverse reactions are described elsewhere in the labeling:

6.1 Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Treatment of gBRCAm HER2-negative Locally Advanced or Metastatic Breast Cancer

EMBRACA

The safety of TALZENNA as monotherapy was evaluated in gBRCAm patients with HER2-negative locally advanced or metastatic breast cancer who had previously received no more than 3 lines of chemotherapy for the treatment of locally advanced/metastatic disease. EMBRACA was a randomized, open-label, multi-center study in which 412 patients received either TALZENNA 1 mg once daily (n=286) or a chemotherapy agent (capecitabine, eribulin, gemcitabine, or vinorelbine) of the healthcare provider’s choice (n=126) until disease progression or unacceptable toxicity. The median duration of study treatment was 6.1 months in patients who received TALZENNA and 3.9 months in patients who received chemotherapy. Dosing interruptions due to an adverse reaction of any grade occurred in 65% of patients receiving TALZENNA and 50% of those receiving chemotherapy; dose reductions due to any cause occurred in 53% of TALZENNA patients and 40% of chemotherapy patients. Permanent discontinuation due to adverse reactions occurred in 5% of TALZENNA patients and 6% chemotherapy patients.

Table 3 and Table 4 summarize the most common adverse reactions and laboratory abnormalities, respectively, in patients treated with TALZENNA or chemotherapy in the EMBRACA study.

Table 3. Adverse Reactions * (in ≥20% of Patients Receiving TALZENNA) in EMBRACA
TALZENNAN=286 (%) ChemotherapyN=126 (%)
Adverse Reactions Grades 1–4 Grade 3 Grade 4 Grades 1–4 Grade 3 Grade 4
Abbreviations: AR=adverse reaction; CTCAE=Common Terminology Criteria for Adverse Events; NCI=National Cancer Institute; N=number of patients.
*
Graded according to NCI CTCAE 4.03.
Includes anemia, hematocrit decreased, hemoglobin decreased, and red blood cell count decreased.
Includes febrile neutropenia, neutropenia and neutrophil count decreased.
§
Includes thrombocytopenia and platelet count decreased.
For TALZENNA, Grade 1 in 23%, and Grade 2 in 2%. For the chemotherapy arm, Grade 1 in 20%, and Grade 2 in 8%.
#
Includes fatigue and asthenia.
Blood and lymphatic system disorders
Anemia 53 38 1 18 4 1
Neutropenia 35 18 3 43 20 16
Thrombocytopenia § 27 11 4 7 2 0
Metabolism and nutrition disorders
Decreased appetite 21 <1 0 22 1 0
Nervous system disorders
Headache 33 2 0 22 1 0
Gastrointestinal disorders
Nausea 49 <1 0 47 2 0
Vomiting 25 2 0 23 2 0
Diarrhea 22 1 0 26 6 0
Skin and subcutaneous tissue disorders
Alopecia 25 0 0 28 0 0
General disorders and administration site conditions
Fatigue # 62 3 0 50 5 0

The following adverse reactions have been identified in <20% of the 286 patients receiving TALZENNA, and thus were not included in Table 3: abdominal pain (19%), dizziness (17%), leukopenia (17%), dysgeusia (10%), dyspepsia (10%), stomatitis (8%), and lymphopenia (7%).

Table 4 Laboratory Abnormalities Reported in ≥25% of Patients in EMBRACA
EMBRACA Study
TALZENNAN *=286 (%) ChemotherapyN *=126 (%)
Parameter Grades 1–4 Grade 3 Grade 4 Grades 1–4 Grade 3 Grade 4
Abbreviation: N=number of patients.
*
This number represents the safety population. The derived values in the table are based on the total number of evaluable patients for each laboratory parameter.
This number represents non-fasting glucose.
Decrease in hemoglobin 90 39 0 77 6 0
Decrease in leukocytes 84 14 0.3 73 22 2
Decrease in neutrophils 68 17 3 70 21 17
Decrease in lymphocytes 76 17 0.7 53 8 0.8
Decrease in platelets 55 11 4 29 2 0
Increase in glucose 54 2 0 51 2 0
Increase in aspartate aminotransferase 37 2 0 48 3 0
Increase in alkaline phosphatase 36 2 0 34 2 0
Increase in alanine aminotransferase 33 1 0 37 2 0
Decrease in calcium 28 1 0 16 0 0

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