The following table summarises the key steps and dates for this application.
|Submission dossier accepted and first round evaluation commenced||2 June 2020|
|First round evaluation completed||2 November 2020|
|Sponsor provides responses on questions raised in first round evaluation||4 January 2021|
|Second round evaluation completed||17 February 2021|
|Delegate's overall benefit-risk assessment||4 May 2021|
|Sponsor's pre-Advisory Committee response||Not applicable|
|Advisory Committee meeting||Not applicable|
|Registration decision (Outcome)||10 May 2021|
|Completion of administrative activities and registration on ARTG||6 September 2021|
|Number of working days from submission dossier acceptance to registration decision*||193|
*Statutory timeframe for standard applications is 255 working days
Dosage of Abevmy is based on multiple factors, including the condition being treated, the body weight of the patient and whether the medicine is used as first or second line treatment.
For further information refer to the Product Information.
Abevmy (bevacizumab) was approved for the following therapeutic use:
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.
Epithelial ovarian, fallopian tube or primary peritoneal cancer
Abevmy (bevacizumab) in combination with 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.
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.
- This approval does not impose any requirement for the submission of periodic safety update reports (PSURs). The sponsor should note that it is a requirement that all existing requirements for the submission of PSURs as a consequence of the initial registration or subsequent changes must be completed.
- Laboratory testing & compliance with Certified Product Details
All batches of Abevmy (bevacizumab) supplied in Australia must comply with the product details and specifications approved during evaluation and detailed in the Certified Product Details (CPD).
When requested by the TGA, the Sponsor should be prepared to provide product samples, specified reference materials and documentary evidence to enable the TGA to conduct laboratory testing on the Product. Outcomes of laboratory testing are published biannually in the TGA Database of Laboratory Testing Results and periodically in testing reports on the TGA website.
Certified Product Details
The CPD, as described in Guidance 7: Certified product details of the Australian regulatory guidelines for prescription medicines (ARGPM), in PDF format, for the above products should be provided upon registration of these therapeutic goods. In addition, an updated CPD should be provided when changes to finished product specifications and test methods are approved in a Category 3 application or notified through a self-assessable change.
- For all injectable products the Product Information must be included with the product as a package insert.