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ABEVMY (Alphapharm Pty Ltd)

Product name
ABEVMY
Date registered
Evaluation commenced
Decision date
Approval time
193 (255 working days)
Active ingredients
bevacizumab
Registration type
New biosimilar medicine
Indication
Metastatic Colorectal Cancer

ABEVMY (bevacizumab) in combination with fluoropyrimidine-based chemotherapy is indicated for the treatment of patients with metastatic colorectal cancer.

Locally recurrent or metastatic Breast Cancer

ABEVMY (bevacizumab) in combination with paclitaxel is indicated for the first-line treatment of metastatic breast cancer in patients in whom an anthracycline-based therapy is contraindicated (see section 5.1 PHARMACODYNAMIC PROPERTIES, Clinical Trials).

Advanced, metastatic or recurrent non-squamous Non-Small Cell Lung Cancer (NSCLC)

ABEVMY (bevacizumab), in combination with carboplatin and paclitaxel, is indicated for firstline treatment of patients with unresectable advanced, metastatic or recurrent, non-squamous, non- small cell lung cancer.

Advanced and/or metastatic Renal Cell Cancer

ABEVMY (bevacizumab) in combination with interferon alfa-2a is indicated for treatment of patients with advanced and/or metastatic renal cell cancer.

Grade IV Glioma

ABEVMY (bevacizumab) as a single agent, is indicated for the treatment of patients with Grade IV glioma after relapse or disease progression after standard therapy, including chemotherapy.

Epith5elial Ovarian, Fallopian Tube or Primary Peritoneal Cancer

ABEVMY (bevacizumab) in combination with5 carboplatin and paclitaxel, is indicated for firstline treatment of patients with advanced (FIGO stages IIIB, IIIC and IV) epithelial ovarian, fallopian tube, or primary peritoneal cancer.

Recurrent Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer

ABEVMY (bevacizumab) in combination with carboplatin and paclitaxel or in combination with carboplatin and gemcitabine, is indicated for the treatment of patients with first recurrence of platinum-sensitive, epithelial ovarian, fallopian tube, or primary peritoneal cancer who have not received prior bevacizumab or other VEGF-targeted angiogenesis inhibitors.

ABEVMY (bevacizumab) in combination with paclitaxel, topotecan or pegylated liposomal doxorubicin is indicated for the treatment of patients with recurrent, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who have received no more than two prior chemotherapy regimens, and have not received any prior anti-angiogenic therapy including bevacizumab.

Cervical Cancer

ABEVMY (bevacizumab) in combination with paclitaxel and cisplatin is indicated for the treatment of persistent, recurrent or metastatic carcinoma of the cervix. ABEVMY (bevacizumab) in combination with paclitaxel and topotecan is an acceptable alternative where cisplatin is not tolerated or not indicated.

The approved indication(s) for TRUCLEVA are:

Metastatic Colorectal Cancer

TRUCLEVA (bevacizumab) in combination with fluoropyrimidine-based chemotherapy is indicated for the treatment of patients with metastatic colorectal cancer.

Locally recurrent or metastatic Breast Cancer

TRUCLEVA (bevacizumab) in combination with paclitaxel is indicated for the first-line treatment of metastatic breast cancer in patients in whom an anthracycline-based therapy is contraindicated. (see section 5.1 PHARMACODYNAMIC PROPERTIES, Clinical Trials).

Advanced, metastatic or recurrent non-squamous Non-Small Cell Lung Cancer (NSCLC)

TRUCLEVA (bevacizumab), in combination with carboplatin and paclitaxel, is indicated for firstline treatment of patients with unresectable advanced, metastatic or recurrent, non-squamous, non- small cell lung cancer.

Advanced and/or metastatic Renal Cell Cancer

TRUCLEVA (bevacizumab) in combination with interferon alfa-2a is indicated for treatment of patients with advanced and/or metastatic renal cell cancer.

Grade IV Glioma

TRUCLEVA (bevacizumab) as a single agent, is indicated for the treatment of patients with Grade IV glioma after relapse or disease progression after standard therapy, including chemotherapy.

Cervical Cancer

TRUCLEVA (bevacizumab) in combination with paclitaxel and cisplatin is indicated for the treatment of persistent, recurrent or metastatic carcinoma of the cervix. TRUCLEVA (bevacizumab) in combination with paclitaxel and topotecan is an acceptable alternative where cisplatin is not tolerated or not indicated.

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