Pharmaceutical Technology Editors

The recent FDA guideline is intended to provide recommendations on conducting bioequivalence (BE) studies during both development and post approval phases for orally administered immediate-release (IR) solid oral dosage forms designed to deliver drugs to the systemic circulation, like tablets, capsules, and granules/powders for oral suspension.

Any deviations from the recommendations in this guideline may be acceptable if appropriate scientific justification is provided. Applicants are encouraged to check the regulatory authority or authorities when an alternate approach is taken.

Articles

Any deviations from the recommendations in this guideline may be acceptable if appropriate scientific justification is provided. 

Bioequivalence for Immediate-Release Solid Oral Dosage Forms 

FDA announced on Jan. 27, 2023, that it has granted accelerated approval to Eli Lilly and Company for Jaypirca (pirtobrutinib) as a treatment for relapsed or refractory mantle cell lymphoma (MCL). Patients who have had at least two lines of systemic therapy, including a bruton tyrosine kinase (BTK) inhibitor, are eligible for the treatment.

Efficacy for pirtobrutinib was evaluated in an open-label, multicenter, single-arm trial (BRUIN [NCT03740529]) of pirtobrutinib monotherapy that included 120 patients with MCL previously treated with a BTK inhibitor. Pirtobrutinib was administered orally at 200 mg once daily and was continued until disease progression or unacceptable toxicity. The main efficacy measures were overall response rate (ORR) and duration of response (DOR). In the results, ORR was measured to be 50%, median DOR was 8.3 months, and the estimated DOR rate at six months was 65.3%.

According to the agency press release, the recommended pirtobrutinib dosage is 200 mg orally once daily until disease progression or unacceptable toxicity. Prior to this accelerated approval, pirtobrutinib received priority review, fast track, and orphan drug designations.

FDA granted accelerated approval to Eli Lilly and Company’s pirtobrutinib for treatment of relapsed or refractory mantle cell lymphoma.

FDA Grants Accelerated Approval to Lilly Cancer Drug

On Jan. 27, 2023, FDA announced that it had approved Stemline Therapeutics’ Orserdu (elacestrant) as a treatment for postmenopausal women or adult men with estrogen-receptor (ER) positive, HER2-negative, estrogen receptor 1 (ESR1)-mutated advanced or metastatic breast cancer with disease progression following at least one line of endocrine therapy. In addition to elacestrant, FDA also approved the Guardant360 companion diagnostic assay to identify patients with breast cancer for treatment with elacestrant.

Efficacy for elacestrant was evaluated in a randomized, open-label, active-controlled, multicenter trial (EMERALD [NCT03778931]) that enrolled 478 postmenopausal women and men with ER-positive, HER2-negative advanced or metastatic breast cancer. Additionally, 228 patients in this population had ESR1 mutations. Patients were randomized (1:1) to receive elacestrant 345 mg orally once daily or the investigator’s choice of endocrine therapy.

The major efficacy outcome measure was progression-free survival (PFS). According to an agency press release, a statistically significant difference in PFS was observed in the full population and in the subgroup of patients with ESR1 mutations. In patients with ESR1 mutations, PFS was 3.8 months for patients treated with elacestrant vs. 1.9 months in those treated with a different endocrine therapy.

The recommended elacestrant dose is 345 mg taken orally with food once daily until disease progression or unacceptable toxicity. Prior to this approval, elacestrant was granted priority review and fast track designation.

FDA approved Stemline Therapeutics’ elacestrant for postmenopausal women or adult men with ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer.

FDA Approves Novel Breast Cancer Treatment

Gerresheimer presents its new Clinical Trial Kit at Pharmapack in Paris on Feb. 1-2, 2023. The kit consists of sterile Gx RTF vials in nest and tub or tray with matching closures and is tailored to requirements to support the development of new drugs, vaccines, and biologics in early phases.
The kit is suitable for small batch manufacturing from first line trials to validation and clinical batches. It can be ordered in six different configurations of Gx RTF Glass Vials. Kits including Gx Elite and Gx RTF COP vials will follow soon.

“There are currently more than 3000 injectable drug programs in pre-clinical and clinical phases. With our clinical trial kits and supportive services, we want to proactively support our customers by providing them with first-class primary packaging solutions,” said Jean-Edouard Rabier, sales development manager and director project management/pharmaceutical services and member of the Gx Biological Solutions Team, in a company press release.

Gerresheimer is presenting its new Clinical Trial Kit to accelerate drug development at Pharmapack in Paris. 

Gerresheimer Presents New Clinical Trial Kit at Pharmapack

Ahead of Pharmapack Europe 2023, taking place on Feb. 1–2, 2023, the event’s panel of experts predict increased consolidations in 2023, driven by supply chain concerns and big pharma preferences. A report to be published at the show, foresees continued challenges ahead for smaller and medium-sized packaging companies that are likely to face significant competitive pressures. The report highlights that many companies are looking to sell products globally, with multiple regulatory burdens and divergent standards. Companies turning over €20 million or less are more likely to be potential acquisition targets.

“Pharma customers like to have suppliers they can reply upon for more than single components (e.g.. cap, bottles, etc.) and increasingly want providers that can provide complete solutions,” said Gregor Nischer, MP corporate finance GmbH managing partner, in a press release. “At the same time, regulations are becoming more complex, and small companies don't have the necessary resources, meaning the development of products is becoming prohibitively expensive.”

The event, which is at the center of pharma’s packaging and drug delivery devices industry, will take place at the Paris Expo, Porte de Versailles (Hall 7.2) and will see 5500 attendees and more than 300 companies.

Pharmapack Europe experts expect smaller and medium European packaging companies to grow or be acquired.

Pharmapack Experts Predict Increased Packaging Consolidations in 2023

Thermo Fisher Scientific and AstraZeneca announced a collaboration to develop a solid tissue and blood-based companion diagnostic (CDx) test for osimertinib (brand name Tagrisso) on Jan. 24, 2023. The CDx is intended to help identify patients with non-small cell lung cancer (NSCLC) who may be eligible for treatment with osimertinib by identifying tumors that exhibit epidermal growth factor receptor (EGFR) alterations, including exon 21 L858R mutations, exon 19 deletions, or T790M mutations.

According to a company press release, the test will use the Oncomine Dx Express Test on the Genexus Dx System, a fully integrated next-generation sequencing platform. The platform features an automated specimen-to-report workflow and can deliver results after 24 hours.

“As part of our ongoing partnership with AstraZeneca, today’s announcement will help bring targeted oncology treatments to more patients in need of new care options,” said Garret Hampton, president of clinical next-generation sequencing and oncology, Thermo Fisher Scientific, in the press release. “By leveraging the Genexus Dx System’s unprecedented turnaround time, we can help ensure molecular testing results are more readily available to inform vital treatment decisions.”

AstraZeneca and Thermo Fisher will collaborate to develop a solid tissue and blood-based companion diagnostic test for osimertinib.