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Safety in Lactation: Other antineoplastic drugs

23 September 2020Antineoplastic agents, whether used as monotherapy or in combination with other antineoplastics, are contra-indicated in breastfeeding (unless indicated below) because of their effects on dividing…
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Refrigerated Storage

AvastinRoche Products Ltd

Roche Products Ltd
Avastin
25mg/mL concentrate for solution for infusion

Contact Roche Products Ltd in all cases where a deviation from the recommended storage conditions has occurred. Refer to the electronic medicines compendium (eMC) at https://www.medicines.org.uk for company contact details and product literature for recommended storage information.

12 October 2022
London MI Service

Lactation Safety Information

No
No published evidence of safety
Serious adverse effects reported in adults
Low levels anticipated in milk due to the drug’s properties and likely to be degraded in infant’s GI tract. However, the effects on the infant of even small amounts in breast milk are unknown
16 September 2020

New Medicines

Information

Lytenava
New formulation
Outlook Therapeutics
Outlook Therapeutics

Development and Regulatory status

None
None
Filing withdrawn
May 22Outlook Therapeutics are seeking to enter into a licensing and/or co-development rights agreement for ONS-5010 in Europe and UK [24].
Apr 22Outlook Therapeutics voluntarily withdraws BLA after conversations with the FDA. The company expects to resubmit the BLA with additional supplemental information by September 2022 [23].
Mar 22Outlook therapeutics announces it has submitted its its Biologics License Application (BLA) to the FDA for ONS-5010 for the treatment of wet AMD [21].
Feb 22If ONS-5010 ophthalmic bevacizumab is approved, Outlook Therapeutics expects to commercialise it as the first and only FDA-approved ophthalmic formulation of bevacizumab for use in treating retinal diseases in the United States, United Kingdom, Europe, Japan and other markets [22].
Dec 21Update from Outlook Therapeutics confirms that, with the registration clinical trials now completed, they intend to submit a BLA to the FDA Q1 2022 with approval anticipated Q1 2023. The company is also developing registration documents on a parallel path for approvals in Europe and expects to submit them shortly after completing the FDA submission. If approved, trials are also planned to investigate use of ONS-5010 in branch retinal vein occlusion and diabetic macular oedema. Outlook also plan to file a supplementary application for approval of the product in a pre-filled, silicone-free syringe, with a trial (NORSE SEVEN) planned to compare the safety of ONS-5010 in vials vs syringes [18].
Jun 21Topline readout of data from PIII NORSE-2 study targeted for calendar Q3 21, and company plans to file a new Biologics License Application (BLA) filing to the FDA Q1 22. Registration documents are also being completed in parallel for approvals in Europe to be submitted shortly after completing the US filing. While Outlook Therapeutics continues to target potential strategic commercialisation partners, particularly for European markets, it is preparing to launch ONS-5010 in the United States by itself, pending FDA approval [17].
Jan 21Outlook Therapeutics announces intention to submit MAA to European Medicines Agency for Retinal disorders in 2021 and commercial launch in 2022 [14].
Dec 20Outlook is in active late-stage discussions for the licensing and/or co-development rights to ONS-5010, but could potentially market it. In the US it believes that ONS-5010 will be entitled to 12 years regulatory exclusivity against biosimilar competition. Despite widespread acceptance and use of bevacizumab to treat ophthalmic diseases such as wet AMD, DME and BRVO, no manufacturer has previously sought approval from FDA or EMA. Products provided off-label by compounding pharmacies can carry known risks of contamination (including silicone oil droplet contamination from syringes) and inconsistent potency, with potentially severe consequences, as leading retinal societies have reported. If ONS-5010 is approved and commercialised, Outlook expects it will be priced responsibly compared to other branded anti-VEGF therapies to help mitigate the high cost of treatment for retinal diseases [16].
Aug 20Based on end-of-Phase 2 discussions with the FDA, Outlook believes that the results from NORSE 1 and NORSE 2, combined with our upcoming NORSE 3 safety study that is designed to ensure an adequate number of patient exposures to ONS-501, will be sufficient to support a new BLA submission in H2 2021 [12].
Aug 20Outlook Therapeutics intends to complete development of ONS-5010 for submission to the FDA as a new BLA under the 351(a) PHSA regulatory pathway for the treatment of wet AMD and also has plans to submit for regulatory approvals in Europe, the UK and Japan, as well as other countries [12].
Jun 20Company is also planning to file in the US for wAMD and other retinal diseases in 2021 [10].
Jun 20Outlook currently intends to commercialize ONS-5010 in both vials and single-use pre-filled syringes [5].
Sep 19Outlook therapeutics plan to submit ONS-5010 for regulatory approval in multiple markets in 2020 [4].
Apr 19the company plan to submit ONS-5010 for regulatory approval in multiple markets in 2020 [3].
Nov 18Oncobiologics is developing ONS-5010 as an innovative therapy and not using the biosimilar drug development pathway [1].

Category

Vascular endothelial growth factor (VEGF) inhibitor
The estimated prevalence of AMD in the UK is 4.8% of those over 65 years of age and 12.2% of those aged 80 years or more. There are around 70,000 new diagnoses in the UK each year [2].
Wet age-related macular degeneration (AMD) - ophthalmic formulation
Intravitreal

Trial or other data

Dec 21Annual update from Outlook reports all three registration trials (NORSE-1, NORSE-2 and NORSE-3) have now completed and data presented at scientific conferences. In NORSE-2, ONS-5010 achieved statistically significant and clinically relevant primary (p = 0.0052) and key secondary (p = 0.0043) efficacy endpoints with 41.7% of subjects gaining at least 15 letters of BVCA. Safety data from NORSE-3 showed no unanticipated safety signals, with no intraocular inflammation or vasculitis, and the frequency and incidence of adverse events and ocular adverse events low. The most common adverse event in the study eye was conjunctival haemorrhage related to injection procedure, not to ONS-5010, and there were no additional serious adverse events associated with these injections. A further open-label trial (NORSE-7; NCT05112861) is also planned in the US to compare the safety of ONS-5010 in vials vs pre-filled syringes in subjects (n=120) with visual impairment due to retinal disorders including exudative AMD, diabetic macular oedema, or branch retinal vein occlusion. Estimated primary completion date is Dec 2022 [18-20].
Jun 21Outlook completes patient dosing in the pivotal PIII NORSE-2 trial [17].
May 21PIII NORSE-1 study is recruiting in Australia; PIII NORSE-2 and NORSE-3 are recruiting in the US [15].
Sep 20PIII NORSE-2 study (NCT03834753) is now due to complete collection of primary outcome data in Jun 2021. PIII NORSE-3 study (NCT04516278) is a 3-month study that will evaluate the safety of ophthalmic bevacizumab in subjects diagnosed with a retinal condition that would benefit from treatment with intravitreal injection of bevacizumab, including: exudative age-related macular degeneration, diabetic macular edema, or branch retinal vein occlusion. 180 adults will be recruited and data collection is expected to complete Mar 21 [13].
Aug 20Outlook Therapeutics expects to report pivotal safety and efficacy data from NORSE 2 in Q3 2021 [12].
Aug 20Top-line results announced demonstrating safety and efficacy of ONS-5010 for the treatment of wet AMD from the NORSE-1 clinical study. Overall, 2 of 25 (8%) patients on ONS-5010 achieved > 15 letters best corrected visual acuity (BCVA) at Month 11 compared to 5 of 23 (22%) patients on the ranibizumab arm, with no statistical differences between ranibizumab and ONS-5010. The results from NORSE 1 met our proof-of-concept expectations and, importantly, validate our confidence in the design of our ongoing NORSE 2 trial [12].
Jun 20PIII trial NORSE-1 (NCT03844074) due to complete August 2020, and NORSE 2 (NCT03834753) due to complete Dec 20 [6].
Sep 19PIII trial NORSE-1 has completed patient recruitment, this is evaluating ONS-5010 against ranibizumab (Lucentis®) for wet AMD [4].
Apr 19ONS-5010-002 is the second PIII clinical trialsevaluating ONS-5010 against ranibizumab (Lucentis®) for wet AMD and will enroll approximately 180 patients (90 in each arm). Patients will be treated for 11 months, the primary outcome is a statistically significant improvement in mean visual acuity of five letters or more for ONS-5010 over ranibizumab [3].
Nov 18Oncobiologics has begun dosing patients in its first clinical trial for ONS-5010 in patients with wet age related macular degeneration (wet AMD) [1].